# FDA recall Z-0911-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-11-11.

## Product

DEXLOCK Achilles Repair Implant Kits, MAKT4520

## 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.

## 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.

## Key facts

- **Recall number:** Z-0911-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-11
- **Report date:** 2025-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0911-2026

## Citation

> AI Analytics. FDA recall Z-0911-2026. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0911-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*