Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Pending LLM rewrite. Source: FDA_DEVICE Z-1518-2026.
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 Replacement Plateau; Item Number: 15-8521/09;
- 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 (10)
- Item Number: 15-8521/09
- UDI-DI: 04026575383238
- Serial/Lot Number: 250728/0038
- 250728/0039
- 250728/0040
- 250728/0041
- 250728/0042
- 250728/0043
- 250728/0044
- 250728/0045
Distribution
Distributed nationwide across the United States.
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