FDA-Device2022-10-12Class II
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Zimmer, Inc.
Hazard
The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.
Sold states
Domestic distribution US nationwide.
Affected count
56 US
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0007-2023Don't want to check this manually?
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