Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Pending LLM rewrite. Source: FDA_DEVICE Z-1513-2026.
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: 16-2840/02;
- 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: 16-2840/02
- UDI-DI: 04026575359233
- Serial/Lot Number: 250925/0640
- 250925/0641
- 250925/0642
- 250925/0646
- 250925/0650
- 250925/0652
- 250925/0653
- 250925/0656
- 250925/0658
- 250925/0669
- 250925/0670
- 250925/0680
- 250925/0681
- 250925/0682
- 250925/0687
- 250925/0689
- 250925/0690
- 250925/0691
Distribution
Distributed nationwide across the United States.
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