Reported Mar 20, 2024 · Ongoing
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Waldemar Link GmbH & Co. KG (Mfg Site)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Waldemar Link GmbH & Co. KG (Mfg Site) · Oststr. 4-10 · Norderstedt, N/A · N/A
Is this the product you have?
- SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
- Lot codes and dates
- 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)
- Product Code (UDI/DI)
- Amount recalled
- 153 Units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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