Reported Mar 18, 2026 · Ongoing
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
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) · Ost Str. 4-10 · Norderstedt, N/A · N/A
Is this the product you have?
- Endo-Model Replacement Plateau
- Item Number15-8521/09
- Lot codes and dates
- Item Number15-8521/09
- UDI-DI04026575383238
- Serial/Lot Number
250728/0038250728/0039250728/0040250728/0041250728/0042250728/0043250728/0044250728/0045
- Amount recalled
- 8 units (OUS only)
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
- NJ
Why it was recalled
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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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