Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Pending LLM rewrite. Source: FDA_DEVICE Z-1514-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
The recalled product
- Product
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Item Number: 16-2840/07
- UDI-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
Distribution
Distributed nationwide across the United States.
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