DEXLOCK Achilles Repair Implant Kits, MAKT4520 recallZ-0911-2026 · Medline Industries, LP · initiated Nov 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0911-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 11, 2025
- Posted by the FDA
- Dec 11, 2025
- Recalling firm
- Medline Industries, LP
- Quantity
- 163 US
- Product code
- NWN
- 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.
Product description
DEXLOCK Achilles Repair Implant Kits, MAKT4520
Code information (models, lots, serial numbers)
Lot 19019 UDI-DI 10193489131703
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE MAKT4520Medline Industries, Inc. · Laparoscopic bone anchor urethropexy instrument kit1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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