Z-0911-2026Class II

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Name: Z-0911-2026 DEXLOCK Achilles Repair Implant Kits, MAKT4520
Creator: Medline Industries, LP
Published: 2025-11-11
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-11-11 / Open, Classified

FDA source

Medline Industries, LP began a recall of DEXLOCK Achilles Repair Implant Kits, MAKT4520 on 2025-11-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0911-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-11
Posted: 2025-12-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: DEXLOCK Achilles Repair Implant Kits, MAKT4520
Product code: NWN Laparoscopic Bone Anchor Urethropexy Instrument Kit
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.
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 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.
Product codes and lots: Lot 19019 UDI-DI 10193489131703

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0911-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0911-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-17	2025-12-11

Product code NWN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)