CLASS II ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report

Dexlock Achilles Repair Implant Kits, MAKT4520 recalled

Medline Industries is recalling Dexlock Achilles Repair Implant Kits, MAKT4520, distributed nationwide in the US. The recall was initiated on 11 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 19019 UDI-DI 10193489131703
Quantity recalled163 US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0911-2026
FDA event ID
98056
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
11 Nov 2025
FDA classified
11 Dec 2025
Reported
17 Dec 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

11 Nov 2025Recall initiated by company
11 Dec 2025Classified by FDA+30 days
17 Dec 2025Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Where it was distributed

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.

Nationwide AlabamaArkansasArizonaColoradoDelawareFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMontanaNorth CarolinaNew JerseyOhioOklahomaPennsylvania

Questions about this recall

Why was it 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.

Which lots are affected?

Lot 19019 UDI-DI 10193489131703

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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