Medical Device Recall: Z-0007-2023

FDA Recalls dataset · Firm: Zimmer, Inc. · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2022-08-25 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-2023.

Recall Res Number
Z-0007-2023
Recalling Firm / Manufacturer
Zimmer, Inc.
FEI Number
1000220733
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2022-08-25
Date Posted
2022-10-05
Date Terminated
N/A
Product Code
OQI
Event Number
90858
Product Quantity
56 US
Product Description G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
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.
Action Details On August 25, 2022, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were instructed to quarantine all affected product. Zimmer Biomet sales representatives will remove the affected product from customer facilities. Customers should ensure that affected personnel are aware of the recall, and also notify any recipients if the product has been further distributed. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Distribution Pattern Domestic distribution US nationwide.
Code Information / Serial Numbers 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

Related Establishments / Registrations

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