Class II — Medline Industries, LP
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | DEXLOCK Achilles Repair Implant Kits, MAKT4520 |
| Quantity | 163 US |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MT, NC, NJ, OH, OK, PA, SC, TX, VA, WI. |
| Initiated | 2025-11-11 |
| Classified | 2025-12-11 |
| Recall number | Z-0911-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medline Industries, LP (Z-0911-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98056/
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