FDA-Device2025-12-17Class IIPROCESSING DEFECT
Medline DEXLOCK Achilles Repair Implant Kit recalled for drill bit fusion
Contact Medline about DEXLOCK Achilles implant kit
Medline Industries is recalling DEXLOCK Achilles Repair Implant Kits (model MAKT4520, lot 19019) because the drill bit can fuse to the drill guide during surgery. This can delay the procedure while a replacement drill bit and guide are retrieved. No patient injuries have been reported.
- If your surgical facility received this kit, contact Medline Industries immediately
- Do not use affected kits (lot 19019) until you receive replacement instructions
- Report any incidents with this product to Medline and the FDA MedWatch program
Hazard
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.
Who it affects
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
163 US
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0911-2026More Medline recalls
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