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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94078

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

Open FDA event record

Event summary

Timeline bucket
February 06, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Waldemar Link GmbH & Co. KG (Mfg Site)

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

4 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 4

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

Z-1296-2024
Recall number
Z-1296-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
382 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Code information

Product Code (UDI/DI): 127-610/17 (04026575387168) , 127-610/26 (04026575387304) , 127-610/35 (04026575387441), 127-612/17 (04026575387175) , 127-612/26 (04026575387311) , 127-612/35 (04026575387458) , 127-614/17 (04026575387182) , 127-614/26 (04026575387328) , 127-614/35 (04026575387465) , 127-616/17 (04026575387199) , 127-616/26 (04026575387335), 127-616/35 (04026575387472) , 127-618/17 (04026575387205) , 127-618/26 (04026575387342) , 127-618/35 (04026575387489) , 127-620/17 (04026575387212) , 127-620/26 (04026575387359) , 127-620/35 (04026575387496) , 127-622/17 (04026575387229) , 127-622/26 (04026575387366) , 127-622/35 (04026575387502) , 127-624/17 (04026575387236) , 127-624/26 (04026575387373) , 127-624/35 (04026575387519) , 127-626/17 (04026575387243) , 127-626/26 (04026575387380) , 127-626/35 (04026575387526) , 127-628/17 (04026575387250) , 127-628/26 (04026575387397) , 127-628/35 (04026575387533) , 127-630/17 (04026575387267) , 127-630/26 (04026575387403) , 127-630/35 (04026575387540) , 127-632/17 (04026575387274) , 127-632/26 (04026575387410) , 127-632/35 (04026575387557) , 127-634/17 (04026575387281) , 127-634/26 (04026575387427) , 127-634/35 (04026575387564) , 127-636/17 (04026575387298) , 127-636/26 (04026575387434) , 127-636/35 (04026575387571), 127-710/17 (04026575232154) , 127-710/26 (04026575232161) , 127-710/35 (04026575232178) , 127-711/17 (04026575232291) , 127-711/26 (04026575232307) , 127-711/35 (04026575232314) , 127-712/17 (04026575232147) , 127-712/26 (04026575024032) , 127-712/35 (04026575024049) , 127-713/17 (04026575232246) , 127-713/26 (04026575024056) , 127-713/35 (04026575024063) , 127-714/17 (04026575232192) , 127-714/26 (04026575024070) , 127-714/35 (04026575024087) , 127-715/17 (04026575230150) , 127-715/26 (04026575024094) , 127-715/35 (04026575024100) , 127-716/17 (04026575232208) , 127-716/26 (04026575024117) , 127-716/35 (04026575024124) , 127-717/17 (04026575232253) , 127-717/26 (04026575024131) , 127-717/35 (04026575024148) , 127-718/17 (04026575232215) , 127-718/26 (04026575024155) , 127-718/35 (04026575024162) , 127-719/17 (04026575232260) , 127-719/26 (04026575024179) , 127-719/35 (04026575024186) , 127-720/17 (04026575229628) , 127-720/26 (04026575225422) , 127-720/35 (04026575225439) , 127-721/17 (04026575229697) , 127-721/26 (04026575225507) , 127-721/35 (04026575225514) , 127-722/17 (04026575229635) , 127-722/26 (04026575024193) , 127-722/35 (04026575024209) , 127-723/17 (04026575229703) , 127-723/26 (04026575024216) , 127-723/35 (04026575024223), 127-724/17 (04026575229642) , 127-724/26 (04026575024230) , 127-724/35 (04026575024247) , 127-725/17 (04026575229710) , 127-725/26 (04026575024254) , 127-725/35 (04026575024261) , 127-726/17 (04026575229659) , 127-726/26 (04026575024278) , 127-726/35 (04026575024285) , 127-727/17 (04026575229727) , 127-727/26 (04026575024292) , 127-727/35 (04026575024308) , 127-728/17 (04026575229666) , 127-728/26 (04026575024315), 127-728/35 (04026575024322) , 127-729/17 (04026575229734) , 127-729/26 (04026575024339) , 127-729/35 (04026575024346) , 127-730/17 (04026575232239) , 127-730/26 (04026575024353) , 127-730/35 (04026575024360) , 127-731/17 (04026575232284) , 127-731/26 (04026575024377) , 127-731/35 (04026575024384) , 127-732/17 (04026575229680) , 127-732/26 (04026575024391) , 127-732/35 (04026575024407) , 127-733/17 (04026575229758) , 127-733/26 (04026575024414) , 127-733/35 (04026575024421) , 127-736/17 (04026575232222) , 127-736/26 (04026575225408) , 127-736/35 (04026575225415) , 127-737/17 (04026575232277) , 127-737/26 (04026575225460) , 127-737/35 (04026575225477) , 127-738/17 (04026575229673) , 127-738/26 (04026575225446) , 127-738/35 (04026575225453) , 127-739/17 (04026575229741) , 127-739/26 (04026575225484) , 127-739/35 (04026575225491);

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.

device · product 2 of 4

SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented

Z-1297-2024
Recall number
Z-1297-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Code information

Product Code (UDI/DI): 127-740/17 (04026575241620) , 127-740/26 (04026575241637) , 127-741/17 (04026575241651) , 127-741/26 (04026575241644) , 127-742/17 (04026575241675) , 127-742/26 (04026575241682) , 127-743/17 (04026575241705) , 127-743/26 (04026575241699) , 127-744/17 (04026575241712) , 127-744/26 (04026575241729) , 127-745/17 (04026575241743) , 127-745/26 (04026575241736) , 127-746/17 (04026575241750) , 127-746/26 (04026575241767) , 127-747/17 (04026575241781) , 127-747/26 (04026575241774) , 127-748/17 (04026575241798) , 127-748/26 (04026575241804) , 127-749/17 (04026575241828) , 127-749/26 (04026575241811), 127-750/17 (04026575241835) , 127-750/26 (04026575241842) , 127-751/17 (04026575241859) , 127-751/26 (04026575242597) , 127-752/17 (04026575241866) , 127-752/26 (04026575241873) , 127-753/17 (04026575241897) , 127-753/26 (04026575241880) , 127-760/17 (04026575241347) , 127-760/26 (04026575241354) , 127-761/17 (04026575241378) , 127-761/26 (04026575241361) , 127-762/17 (04026575241385) , 127-762/26 (04026575241392) , 127-763/17 (04026575241415) , 127-763/26 (04026575241408) , 127-764/17 (04026575241422) , 127-764/26 (04026575241439) , 127-765/17 (04026575241453) , 127-765/26 (04026575241446), 127-766/17 (04026575241460) , 127-766/26 (04026575241477) , 127-767/17 (04026575241491) , 127-767/26 (04026575241484) , 127-768/17 (04026575241507) , 127-768/26 (04026575241514) , 127-769/17 (04026575241538) , 127-769/26 (04026575241521) , 127-770/17 (04026575241545) , 127-770/26 (04026575241552) , 127-771/17 (04026575241576) , 127-771/26 (04026575241569) , 127-772/17 (04026575241583) , 127-772/26 (04026575241590) , 127-773/17 (04026575241613) , 127-773/26 (04026575241606);

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.

device · product 3 of 4

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Z-1298-2024
Recall number
Z-1298-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
153 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Code information

Product Code (UDI/DI): 127-910/26 (04026575024872) , 127-910/35 (04026575024889) , 127-911/26 (04026575024902) , 127-911/35 (04026575024919) , 127-912/26 (04026575024933) , 127-912/35 (04026575024940) , 127-913/26 (04026575024964) , 127-913/35 (04026575024971) , 127-914/26 (04026575024995) , 127-914/35 (04026575025008) , 127-915/26 (04026575025022) , 127-915/35 (04026575025039) , 127-916/26 (04026575025053) , 127-916/35 (04026575025060) , 127-917/26 (04026575025084) , 127-917/35 (04026575025091), 127-918/26 (04026575025114) , 127-918/35 (04026575025121) , 127-919/26 (04026575025145) , 127-919/35 (04026575025152) , 127-920/26 (04026575025176) , 127-920/35 (04026575025183) , 127-921/26 (04026575025206) , 127-921/35 (04026575025213) , 127-922/26 (04026575025237) , 127-922/35 (04026575025244) , 127-923/26 (04026575025268) , 127-923/35 (04026575025275) , 127-924/26 (04026575025299) , 127-924/35 (04026575025305) , 127-925/26 (04026575025329) , 127-925/35 (04026575025336), 127-926/26 (04026575025350) , 127-926/35 (04026575025367) , 127-927/26 (04026575025381) , 127-927/35 (04026575025398) , 127-928/26 (04026575025411), 127-928/35 (04026575025428) , 127-929/26 (04026575025442) , 127-929/35 (04026575025459) , 127-930/26 (04026575025473) , 127-930/35 (04026575025480) , 127-931/26 (04026575025503) , 127-931/35 (04026575025510) , 127-932/26 (04026575025534) , 127-932/35 (04026575025541) , 127-933/26 (04026575025565) , 127-933/35 (04026575025572);

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.

device · product 4 of 4

SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

Z-1299-2024
Recall number
Z-1299-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Code information

Product Code (UDI/DI): 127-940/26 (04026575335572) , 127-940/35 (04026575335589) , 127-941/26 (04026575335596) , 127-941/35 (04026575335602) , 127-942/26 (04026575335619) , 127-942/35 (04026575335626) , 127-943/26 (04026575335633) , 127-943/35 (04026575335640) , 127-944/26 (04026575335657) , 127-944/35 (04026575335664) , 127-945/26 (04026575335671) , 127-945/35 (04026575335688) , 127-946/26 (04026575335695) , 127-946/35 (04026575335701) , 127-947/26 (04026575335718) , 127-947/35 (04026575335725), 127-948/26 (04026575335732) , 127-948/35 (04026575335749) , 127-949/26 (04026575335756) , 127-949/35 (04026575335763) , 127-950/26 (04026575335770) , 127-950/35 (04026575335787) , 127-951/26 (04026575335794) , 127-951/35 (04026575335800) , 127-952/26 (04026575335817) , 127-952/35 (04026575335824) , 127-953/26 (04026575335831) , 127-953/35 (04026575335848) , 127-954/26 (04026575335855) , 127-954/35 (04026575335862) , 127-955/26 (04026575335879) , 127-955/35 (04026575335886), 127-956/26 (04026575335893) , 127-956/35 (04026575335909) , 127-957/26 (04026575335916) , 127-957/35 (04026575335923) , 127-958/26 (04026575335930) , 127-958/35 (04026575335947) , 127-959/26 (04026575335954) , 127-959/35 (04026575335961) , 127-960/26 (04026575335978) , 127-960/35 (04026575335985) , 127-961/26 (04026575335992) , 127-961/35 (04026575336005) , 127-962/26 (04026575336012) , 127-962/35 (04026575336029) , 127-963/26 (04026575336036) , 127-963/35 (04026575336043);

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.

Field note

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