Waldemar Link SPII Lubinus Prosthesis XL Neck Recall: Label Misinterpretation Risk
Waldemar Link recalls SPII Model Lubinus Long Stem Prosthesis XL Neck cemented implants due to potential misinterpretation of carton labels during surgery. Affected units have specific product codes.
Lower-risk 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.
Contact the company
What happened, in plain English
Waldemar Link is recalling certain long stem prosthesis XL neck implants because carton labels may be misinterpreted during surgery. This could lead to incorrect surgical decisions if the size and type columns are not read correctly. Read more at govinfonow.com/recall/56187-waldemar-link-spii-lubinus-prosthesis-xl-neck-recall-label-misinterpretation.
Source Summary by GovInfoNow · govinfonow.com/recall/56187-waldemar-link-spii-lubinus-prosthesis-xl-neck-recall-label-misinterpretation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1299-2024
Cite this page
“Waldemar Link SPII Lubinus Prosthesis XL Neck Recall: Label Misinterpretation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56187-waldemar-link-spii-lubinus-prosthesis-xl-neck-recall-label-misinterpretation. Based on FDA recall #Z-1299-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2024%22&limit=1).
Why it’s dangerous
The carton labels for size and type columns could be misinterpreted during surgery, potentially leading to incorrect implant selection. This is based on two complaints about label interpretation, not actual injuries.
Who’s affected
Orthopedic surgeons and medical professionals who use these implants during hip replacement surgeries. Patients who received these specific implant models are not at risk from the recall itself.
How to tell if you have this one
Check for product codes starting with 127-940/26 through 127-963/35 in the carton. These codes correspond to specific models of the SPII Lubinus Long Stem Prosthesis XL Neck cemented implants.
- Brand
Waldemar Link- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1296-2024 | SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented; 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); | 382 units |
| Z-1297-2024 | SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented; 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); | 34 units |
| Z-1298-2024 | SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented; 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); | 153 Units |
| Z-1299-2024 | SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented; 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); | 0 units |
What to do — step by step
Review Carton Labels
Check the carton for size and type columns to ensure correct interpretation before surgery.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 20 states.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Nevada, New Jersey, Pennsylvania, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 43 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1299-2024 (February 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1299-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.