DEXLOCK Achilles Repair Implant Kits, MAKT4520
Pending LLM rewrite. Source: FDA_DEVICE Z-0911-2026.
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
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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