Recall Z-1731-2022— Exactech, Inc.

Name: FDA recall Z-1731-2022
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: K100269. Product: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;. 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

K100269 — NOVATION CROWN CUP GXL LINERSExactech, Inc.·cleared 2010-05-27

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. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

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.