Acumatch L-Series BIPOLAR LINER — Class II medical device recall Z-2236-2024
Ongoing recall by Exactech, Inc., reported 2024-07-10, distributed in PR. The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene
| Recall number | Z-2236-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2024-04-26 |
| Classified | 2024-06-28 |
| Reported by FDA | 2024-07-10 |
| Distributed | PR |
| Countries outside the US | GB, JP |
| Quantity | 589 units |
| UPC / GTIN / UDI-DI | 10885862009302, 10885862009319, 10885862009326, 10885862009333, 10885862009340, 10885862009357, 10885862009364 |
| Lot numbers | 1766644, 1766645, 1766646, 1766647, 1766648, 1766649, 1766650, 1766651, 1766652, 1766653, 1766654, 1766655, 1766656, 1766657, 1766658, 1766659, 1766660, 1766661, 1766662, 1766663, 1766664, 1766665, 1766666, 1766667, 1766668, 1766669, 1766670, 1973674, 1973675, 1973676, 1973677, 1973678, 1973679, 1973680, 1973681, 1973682, 1973683, 1973684, 1973685, 1973686 and 460 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2236-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.