FDA Device recall Z-0911-2026
DEXLOCK Achilles Repair Implant Kits, MAKT4520
- FDA Device
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of DEXLOCK Achilles Repair Implant Kits, MAKT4520 by Medline Industries, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0911-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-11 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Reason
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.
Identifiers
| code_info | Lot 19019 UDI-DI 10193489131703 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0911-2026%22
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