Reported Mar 18, 2026 · Ongoing
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
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 SL Connection Component incl. PE-Plateau
- Item Number16-2840/07
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 16-2840/07— — 04026575359257UDI-DI: 04026575359257 — Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367 - Amount recalled
- 31 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.
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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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