Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Pending LLM rewrite. Source: FDA_DEVICE Z-1520-2026.
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: 15-8521/15;
- 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 (6)
- Item Number: 15-8521/15
- UDI-DI: 04026575383283
- Serial/Lot Number: 250805/0020
- 250805/0021
- 250805/0023
- 250805/0024
Distribution
Distributed nationwide across the United States.
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