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U.S. Department of Health and Human Services

Class 2 Device Recall G7 Acetabular System

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  Class 2 Device Recall G7 Acetabular System see related information
Date Initiated by Firm August 25, 2022
Date Posted October 05, 2022
Recall Status1 Open3, Classified
Recall Number Z-0007-2023
Recall Event ID 90858
510(K)Number K121874  
Product Classification Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented - Product Code OQI
Product G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
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
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Customer Service
574-267-6131
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 56 US
Distribution Domestic distribution US nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OQI and Original Applicant = BIOMET MANUFACTURING CORP.
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