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Recall Observatory FDA recall evidence

Device product

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

Z-1284-2023

February 06, 2023

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 91866
Status
Ongoing
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-1284-2023

Official wording

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.

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

Distribution pattern: US Distribution to states of: AZ, FL, GA, MI, NE, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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