Medline Industries, LP recalls DEXLOCK Achilles Repair Implant Kits

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0911-2026
• FDA device classification · NWNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medline Industries, LPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.