DEXLOCK Achilles Repair Implant Kits, MAKT4520

FDA device recall Z-0911-2026 · posted 2025-12-11 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NWN

Quantity affected

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.

Date initiated

2025-11-11

Date posted

2025-12-11

Location

Northfield, IL