[pending] Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Pending LLM rewrite. Source: FDA_DEVICE Z-1517-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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: 15-8030/12;
- 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: 15-8030/12
- UDI-DI: 04026575048151
- Serial/Lot Number: 250721/0194
- 250721/0212
- 250721/0211
- 250721/0209
Distribution
Distributed nationwide across the United States.
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