DEXLOCK Achilles Repair Implant Kits — Class II medical device recall Z-0911-2026
Ongoing recall by Medline Industries, LP, reported 2025-12-17, distributed nationwide. There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during us
| Recall number | Z-0911-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-11-11 |
| Classified | 2025-12-11 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 163 us |
| UPC / GTIN / UDI-DI | 10193489131703 |
| Lot numbers | 19019 |
Product
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0911-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.