Recall Z-2236-2024— Exactech, Inc.

Name: FDA recall Z-2236-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-26

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2024-04-26. It names one FDA 510(k) clearance: K013211. 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: 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..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-26
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K013211 — MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESISExactech, Inc.·cleared 2001-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.