FDAClass IIMarch 29, 2023

G7 Acetabular System recall: Labeling Error

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

Why was G7 Acetabular System recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: (01)00880304703506(17)321128(10)65731960; Lot Number: 65731960

Product
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Recalling firm
Biomet, Inc.
Quantity
12 units
Distribution
US Distribution to states of: AZ, FL, GA, MI, NE, and TX.
Recall date
March 29, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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