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Recall Observatory FDA recall evidence

Device product

G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty

Z-0007-2023

August 25, 2022

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 90858
Status
Ongoing
Classification
Class II
Quantity
56 US
Official record key
device-enforcement:Z-0007-2023

Official wording

Reason: 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.

Code information: Item No. 010000663 UDI-DI: 00880304524224 Lots: 7286477 7289929 7296576 7296633 7301697 Exp. 21-Jul-32 Item No. 010000667 UDI-DI: 00880304524262 Lot: 7253325 Exp. 13-Jun-32

Distribution pattern: Domestic distribution US nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.