Drug recall
DEXLOCK Achilles Repair Implant Kits, MAKT4520
FDA recall event 98056 · Class II · Medline Industries, LP
Key facts
| Event ID | 98056 |
|---|---|
| Recall numbers | Z-0911-2026 |
| Recalling firm | Medline Industries, LP |
| Product type | Devices |
| Products | DEXLOCK Achilles Repair Implant Kits, MAKT4520 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Nov 11, 2025 |
| Report date | Dec 17, 2025 |
| City | Northfield |
| State | IL |
| Country | United States |
| FEI number | 1417592 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: