Recall Z-1726-2022— Exactech, Inc.

Name: FDA recall Z-1726-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-11

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2022-08-11. It names one FDA 510(k) clearance: K040613. Product: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04. Reason: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-11
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K040613 — EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERSExactech, Inc.·cleared 2004-06-04

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

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04

Reason for recall

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

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