# FDA recall Z-2236-2024

> **Exactech, Inc.** · Class II · device recall initiated 2024-04-26.

## Product

Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers:      a) 100-22-19, SZ. L;   b) 100-22-20, SZ. M;   c) 100-22-21, SZ. N;   d) 100-22-22, SZ. P;   e) 100-22-23, SZ. R;   f) 100-22-24, SZ. S;   g) 100-22-25, SZ. T

## Reason for recall

The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.

## Distribution

Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan.

## Key facts

- **Recall number:** Z-2236-2024
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-26
- **Report date:** 2024-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2236-2024

## Citation

> AI Analytics. FDA recall Z-2236-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2236-2024. Source: US FDA. Licensed CC0.

---

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