Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Pending LLM rewrite. Source: FDA_DEVICE Z-1511-2026.
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: 16-2840/05;
- 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: 16-2840/05
- 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
Distribution
Distributed nationwide across the United States.
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