G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip
Summary
The FDA issued a Class II for G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 by Zimmer, Inc.. Reason: The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during tran.
Details
Source
Device Recall
External ID
Z-0007-2023
Action Date
2022-10-12
Status
Ongoing
Category
device
Product Description
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Lot/Code Info: 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
Quantity Affected: 56 US
Reason for Recall
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.
Distribution
Domestic distribution US nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-25
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer, Inc. have FDA actions?
Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0007-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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