FDA Medical devices recall ·
DEXLOCK Achilles Repair Implant Kits, MAKT4520 recall
- Recall number
- Z-0911-2026
- Date
- (initiated November 11, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 163 US
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DEXLOCK Achilles Repair Implant Kits, MAKT4520
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 19019 UDI-DI 10193489131703
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.
States: Alabama Arkansas Arizona Colorado Delaware Florida Georgia Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Montana North Carolina New Jersey Ohio Oklahoma Pennsylvania South Carolina Texas Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0911-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.