G7 Acetabular Liner Recalled for Size and Label Discrepancy
Biomet recalled 12 units of its G7 Acetabular System 40mm Size D Liner because the actual implant is a 38mm Size C. The mismatch between outer labeling and the actual implant could result in wrong-size component placement during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where no injuries have been reported. An incorrectly sized hip implant component could result in surgical complications or need for revision surgery, but the hazard is theoretical without reported adverse events. FDA Class II classification with no hospitalization reports does not elevate the score beyond this level.
Plain-English summary
Biomet, Inc. has recalled 12 units of the G7 Acetabular System, Dual Mobility Acetabular Liner, Model Number 110024462 (Lot Number 65731960). These units were distributed to healthcare facilities in Arizona, Florida, Georgia, Michigan, Nebraska, and Texas.
The outer package labeling and product etch on each unit indicate a 40 mm Size D liner, but the actual implant is a 38 mm Size C liner. This discrepancy between what the label states and what the package contains creates a risk of wrong-size component placement during surgery.
This is an FDA Class II recall. No injuries or adverse events have been reported related to this recall. The recalling manufacturer is Biomet, Inc.
The recalled product
- Product
- G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
- Manufacturer
- Biomet, Inc.
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: (01)00880304703506(17)321128(10)65731960
- Lot Number: 65731960
Distribution
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