[pending] DEXLOCK Achilles Repair Implant Kits, MAKT4520
Pending LLM rewrite. Source: FDA_DEVICE Z-0911-2026.
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
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
The recalled product
- Product
- DEXLOCK Achilles Repair Implant Kits, MAKT4520
- Manufacturer
- Medline Industries, LP
- 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 (1)
- Lot 19019 UDI-DI 10193489131703
Distribution
Distributed nationwide across the United States.
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