DEXLOCK Achilles Repair Implant Kits, MAKT4520
This recall is currently active, issued December 11, 2025.
- Recall Initiated
- November 11, 2025
- Posted
- December 11, 2025
- Recall Number
- Z-0911-2026
- Quantity
- 163 US
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lot 19019 UDI-DI 10193489131703
Root Cause
Under Investigation by firm
Action Taken
Firm began notifying consignees on 11/11/2025 via Urgent Medical Device Recall letters. Customers have been instructed to over-label kits with a sticker instructing them to not use the drill guide within the Achilles Kit and to use the reusable 3.6mm drill guide from the Soft Tissue Instrument Tray. Customers who do not have a Soft Tissue Instrument Tray have been instructed to notify Medline so that a tray can be provided. Customers were instructed to quarantine all affected product in stock and return a completed response form to Medline. Upon receipt of the response form, the firm will then provide over-labels to place on affected inventory. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.