Recall Z-0911-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2025-11-11. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-11-11
- Firm location
- Northfield, IL, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.