Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80520

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

Open FDA event record

Event summary

Timeline bucket
June 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ossur Americas

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

8 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 8

Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK

Z-0997-2019
Recall number
Z-0997-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
372

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Code information

All lots of the products manufactured from 06/30/2009 - 12/13/2018 Titanium Pin Label Mistakenly lists Ceramic Tip, Part/Lot numbers: 516TS/ AL18021418 and AL17022109; 520TS/ AL18021417 and AL15091012

Distribution pattern

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

device · product 2 of 8

Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN 2-1/4 CT 6 PK

Z-0998-2019
Recall number
Z-0998-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
824

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Code information

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution pattern

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

device · product 3 of 8

Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No App; 540D/ OB RESOLVE COMPONENT TRAY

Z-0999-2019
Recall number
Z-0999-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
342

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Code information

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution pattern

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

device · product 4 of 8

Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT LG-No App; 540C/ CB RESOLVE COMPONENT TRAY; 553CB/ CB RING TRAY SM; 554CB/ CB RING TRAY STD; 555CB/ CB RING TRAY LG; 505301C/ Kit Closed Back Halo Sm; 505401C/ Kit Closed Back Halo Md; 505501C/ Kit Closed Back Halo Lg

Z-1000-2019
Recall number
Z-1000-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
656

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Code information

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution pattern

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

device · product 5 of 8

Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB V2 RING KIT TI STD-No App; 515500T/ CB RING KIT TI LG-No App; 515500V2/ OB V2 RING KIT TI LG-No App; 515300T/ CB RING KIT TI SM-No App; 515400T/ CB RING KIT TI STD-No App; 515301T/ CB RING KIT TI SM 8-No APP; 515301V2/ OB V2 RING KIT TI SM 8-No App; 515401T/ CB RING KIT TI STD 8-No APP; 515401V2/ OB V2 RING KIT TI STD 8-No APP; 515501T/ CB RING KIT TI LG 8-No App; 515501V2/ OB V2 RING KIT TI LG 8-No App; 540T/ STERILE TITANIUM COMP TRAY; 540V2/ STERILE V2 COMPONENT TRAY

Z-1001-2019
Recall number
Z-1001-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
182

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Code information

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution pattern

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

device · product 6 of 8

Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY

Z-1002-2019
Recall number
Z-1002-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
138

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Code information

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution pattern

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

device · product 7 of 8

Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool

Z-1003-2019
Recall number
Z-1003-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
381

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Code information

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution pattern

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

device · product 8 of 8

Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX

Z-1004-2019
Recall number
Z-1004-2019
Initiated
June 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas
Quantity
45

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Code information

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution pattern

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

Field note

Send feedback

We'll only use this to respond to your feedback.