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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86164

22 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 22, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Globus Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

22 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 22

ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)

Z-2850-2020
Recall number
Z-2850-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1111S; Lot#/UDI #: GBX132UC / (01)00889095720723(17)250511(10)GBX132UC

Distribution pattern

Worldwide Distribution

device · product 2 of 22

ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿

Z-2851-2020
Recall number
Z-2851-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1011; Lot #/ UDI #: BAX112RE / (01)00889095258356(10)BAX112RE; BAX125YE / (01)00889095258356(10)BAX125YE; BAX134BE / (01)00889095258356(10)BAX134BE; BAX095YE / (01)00889095258356(10)BAX095YE; BAX177TE / (01)00889095258356(10)BAX177TE; BAX177RE / (01)00889095258356(10)BAX177RE; BAX185AE / (01)00889095258356(10)BAX185AE; BAX096AE / (01)00889095258356(10)BAX096AE; BAX167ME / (01)00889095258356(10)BAX167ME; BAX195UE / (01)00889095258356(10)BAX195UE; BAX209SE / (01)00889095258356(10)BAX209SE; BAX209TE / (01)00889095258356(10)BAX209TE; BAX244HE / (01)00889095258356(10)BAX244HE; BAX250DE / (01)00889095258356(10)BAX250DE; BAX299JE / (01)00889095258356(10)BAX299JE; BAX398VE / (01)00889095258356(10)BAX398VE; BAX431TE / (01)00889095258356(10)BAX156LE

Distribution pattern

Worldwide Distribution

device · product 3 of 22

ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿

Z-2852-2020
Recall number
Z-2852-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1012; Lot # / UDI #: BAX096BE / (01)00889095258363(10)BAX096BE; BAX112TE / (01)00889095258363(10)BAX112TE; BAX112SE / (01)00889095258363(10)BAX112SE; BAX177UE / (01)00889095258363(10)BAX177UE; BAX195VE / (01)00889095258363(10)BAX195VE; BAX229TE / (01)00889095258363(10)BAX229TE; BAX279WE / (01)00889095258363(10)BAX279WE; BAX288HE / (01)00889095258363(10)BAX288HE; BAX299GE / (01)00889095258363(10)BAX299GE; BAX367FE / (01)00889095258363(10)BAX367FE

Distribution pattern

Worldwide Distribution

device · product 4 of 22

ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿

Z-2853-2020
Recall number
Z-2853-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1013; Lot # / UDI #: BAX104GE / (01)00889095069495(10)BAX104GE; BAX156GE / (01)00889095069495(10)BAX156GE; BAX156HE / (01)00889095069495(10)BAX156HE; BAX195WE / (01)00889095069495(10)BAX195WE; BAX361LE / (01)00889095069495(10)BAX361LE

Distribution pattern

Worldwide Distribution

device · product 5 of 22

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿

Z-2854-2020
Recall number
Z-2854-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1015; Lot # / UDI #: BAX156KE / (01)00889095069518(10)BAX156KE; BAX156LE / (01)00889095069518(10)BAX156LE; BAX308CE / (01)00889095069518(10)BAX308CE; BAX308DE / (01)00889095069518(10)BAX308DE

Distribution pattern

Worldwide Distribution

device · product 6 of 22

ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿

Z-2855-2020
Recall number
Z-2855-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1032; Lot # / UDI #: BAX095XE / (01)00889095069549(10)BAX095XE; BAX175CE / (01)00889095069549(10)BAX175CE; BAX185BE / (01)00889095069549(10)BAX185BE; BAX299LE / (01)00889095069549(10)BAX299LE

Distribution pattern

Worldwide Distribution

device · product 7 of 22

ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿

Z-2856-2020
Recall number
Z-2856-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1033; Lot # / UDI #: BAX112VE / (01)00889095069556(10)BAX112VE; BAX126AE / (01)00889095069556(10)BAX126AE; BAX126WE / (01)00889095069556(10)BAX126WE; BAX207AE / (01)00889095069556(10)BAX207AE; BAX244KE / (01)00889095069556(10)BAX244KE; BAX264UE / (01)00889095069556(10)BAX264UE; BAX256DE / (01)00889095069556(10)BAX256DE; BAX348DE / (01)00889095069556(10)BAX348DE; BAX351NE / (01)00889095069556(10)BAX351NE

Distribution pattern

Worldwide Distribution

device · product 8 of 22

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿

Z-2857-2020
Recall number
Z-2857-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1035; Lot # / UDI #: BAX112UE / (01)00889095069570(10)BAX112UE; BAX212UE / (01)00889095069570(10)BAX212UE; BAX219JE / (01)00889095069570(10)BAX219JE; BAX348AE / (01)00889095069570(10)BAX348AE; BAX367GE / (01)00889095069570(10)BAX367GE; BAX431UE / (01)00889095069570(10)BAX431UE

Distribution pattern

Worldwide Distribution

device · product 9 of 22

ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿

Z-2858-2020
Recall number
Z-2858-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1111; Lot # / UDI #: BAX156ME / (01)00889095069679(10)BAX156ME; BAX156NE / (01)00889095069679(10)BAX156NE; BAX167PE / (01)00889095069679(10)BAX167PE; BAX229VE / (01)00889095069679(10)BAX229VE; BAX290TE / (01)00889095069679(10)BAX290TE; BAX290UE / (01)00889095069679(10)BAX290UE; BAX294WE / (01)00889095069679(10)BAX294WE; BAX376DE / (01)00889095069679(10)BAX376DE; BAX376CE / (01)00889095069679(10)BAX376CE

Distribution pattern

Worldwide Distribution

device · product 10 of 22

ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿

Z-2859-2020
Recall number
Z-2859-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1112; Lot # / UDI #: BAX137PE / (01)00889095069686(10)BAX137PE; BAX167SE / (01)00889095069686(10)BAX167SE; BAX178FE / (01)00889095069686(10)BAX178FE; BAX208LE / (01)00889095069686(10)BAX208LE; BAX250CE / (01)00889095069686(10)BAX250CE; BAX348CE / (01)00889095069686(10)BAX348CE; BAX431NE / (01)00889095069686(10)BAX431NE

Distribution pattern

Worldwide Distribution

device · product 11 of 22

ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿

Z-2860-2020
Recall number
Z-2860-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1113; Lot # / UDI #: BAX178LE / (01)00889095069693(10)BAX178LE; BAX178KE / (01)00889095069693(10)BAX178KE; BAX189PE / (01)00889095069693(10)BAX189PE; BAX348EE / (01)00889095069693(10)BAX348EE

Distribution pattern

Worldwide Distribution

device · product 12 of 22

ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿

Z-2861-2020
Recall number
Z-2861-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1115; Lot # / UDI #: BAX159RE / (01)00889095069716(10)BAX159RE; BAX178JE / (01)00889095069716(10)BAX178JE; BAX208RE / (01)00889095069716(10)BAX208RE; BAX229UE / (01)00889095069716(10)BAX229UE; BAX250BE / (01)00889095069716(10)BAX250BE; BAX308BE / (01)00889095069716(10)BAX308BE; BAX347YE / (01)00889095069716(10)BAX347YE; BAX351KE / (01)00889095069716(10)BAX351KE

Distribution pattern

Worldwide Distribution

device · product 13 of 22

ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿

Z-2862-2020
Recall number
Z-2862-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1132; Lot# / UDI #: BAX138HE / (01)00889095069747(10)BAX138HE; BAX177XE / (01)00889095069747(10)BAX177XE; BAX185CE / (01)00889095069747(10)BAX185CE; BAX195EE / (01)00889095069747(10)BAX195EE; BAX208NE / (01)00889095069747(10)BAX208NE; BAX299PE / (01)00889095069747(10)BAX299PE; BAX315CE / (01)00889095069747(10)BAX315CE; BAX348BE / (01)00889095069747(10)BAX348BE

Distribution pattern

Worldwide Distribution

device · product 14 of 22

ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿

Z-2863-2020
Recall number
Z-2863-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1133; Lot # / UDI #: BAX108TE / (01)00889095069754(10)BAX108TE; BAX178ME / (01)00889095069754(10)BAX178ME; BAX208TE / (01)00889095069754(10)BAX208TE; BAX299NE / (01)00889095069754(10)BAX299NE; BAX413CE / (01)00889095069754(10)BAX413CE; BAX413GE / (01)00889095069754(10)BAX413GE

Distribution pattern

Worldwide Distribution

device · product 15 of 22

ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿

Z-2864-2020
Recall number
Z-2864-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1135; Lot # / UDI #: BAX178PE / (01)00889095069778(10)BAX178PE; BAX236NE / (01)00889095069778(10)BAX236NE; BAX398UE / (01)00889095069778(10)BAX398UE; BAX431SE / (01)00889095069778(10)BAX431SE

Distribution pattern

Worldwide Distribution

device · product 16 of 22

ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿

Z-2865-2020
Recall number
Z-2865-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1211; Lot # / UDI #: BAX103VE / (01)00889095069877(10)BAX103VE; BAX109ME / (01)00889095069877(10)BAX109ME; BAX203PE / (01)00889095069877(10)BAX203PE; BAX315BE / (01)00889095069877(10)BAX315BE; BAX359ME / (01)00889095069877(10)BAX359ME; BAX412WE / (01)00889095069877(10)BAX412WE

Distribution pattern

Worldwide Distribution

device · product 17 of 22

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿

Z-2866-2020
Recall number
Z-2866-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1212; Lot # / UDI #: BAX103XE / (01)00889095069884(10)BAX103XE; BAX109NE / (01)00889095069884(10)BAX109NE; BAX250HE / (01)00889095069884(10)BAX250HE; BAX250FE / (01)00889095069884(10)BAX250FE; BAX256CE / (01)00889095069884(10)BAX256CE; BAX257UE / (01)00889095069884(10)BAX257UE

Distribution pattern

Worldwide Distribution

device · product 18 of 22

ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿

Z-2867-2020
Recall number
Z-2867-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1213; Lot # / UDI #: BAX128PE / (01)00889095069891(10)BAX128PE; BAX207CE / (01)00889095069891(10)BAX207CE; BAX128NE / (01)00889095069891(10)BAX128NE; BAX250EE / (01)00889095069891(10)BAX250EE; BAX256BE / (01)00889095069891(10)BAX256BE

Distribution pattern

Worldwide Distribution

device · product 19 of 22

ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿

Z-2868-2020
Recall number
Z-2868-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1215; Lot # / UDI #: BAX112XE / (01)00889095069914(10)BAX112XE; BAX250LE / (01)00889095069914(10)BAX250LE

Distribution pattern

Worldwide Distribution

device · product 20 of 22

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿

Z-2869-2020
Recall number
Z-2869-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1232; Lot # / UDI #: BAX103UE / (01)00889095069945(10)BAX103UE; BAX138JE / (01)00889095069945(10)BAX138JE; BAX167VE / (01)00889095069945(10)BAX167VE; BAX167UE / (01)00889095069945(10)BAX167UE; BAX227JE / (01)00889095069945(10)BAX227JE; BAX413ME / (01)00889095069945(10)BAX413ME

Distribution pattern

Worldwide Distribution

device · product 21 of 22

ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿

Z-2870-2020
Recall number
Z-2870-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1233; Lot # /UDI #: BAX196AE / (01)00889095069952(10)BAX196AE; BAX196CE / (01)00889095069952(10)BAX196CE

Distribution pattern

Worldwide Distribution

device · product 22 of 22

ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿

Z-2871-2020
Recall number
Z-2871-2020
Initiated
July 22, 2020
Classification
Class II
Status
Terminated
Recalling firm
Globus Medical, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information

Part #: 1124.1235; Lot # / UDI #: BAX103WE / (01)00889095069976(10)BAX103WE; BAX227VE / (01)00889095069976(10)BAX227VE

Distribution pattern

Worldwide Distribution

Field note

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