Reported Mar 18, 2026 · Ongoing

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

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

Lot codes and dates: 3 of 3 products
Products covered by this recall
Model / number Barcodes Product as published
16-2840/05 —
— 04026575359240 UDI-DI: 04026575359240
— Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254
Amount recalled: 44 units (1 US, 43 OUS)

The agency filed one notice per product. You are reading one of them; the other 12 are below.

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.

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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