DEXLOCK Achilles Repair Implant Kits, MAKT4520
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 11, 2025 |
| Reported | December 17, 2025 |
| Recalling firm | Medline Industries, LP |
| Country / region | United States IL |
Hazard
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.
Affected products
- DEXLOCK Achilles Repair Implant Kits, MAKT4520
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