Recall Z-1284-2023— Biomet, Inc.

Name: FDA recall Z-1284-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-06

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2023-02-06. It names one FDA 510(k) clearance: K150522. Product: G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462. Reason: The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-06
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K150522 — G7 Dual Mobility SystemBiomet, Inc.·cleared 2015-05-01

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

G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

Reason for recall

The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

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