G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip
FDA device recall Z-0007-2023 · posted 2022-10-05 · Open, Classified
Recall details
- Recalling firm
- Zimmer, Inc.
- 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 taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OQI
- Quantity affected
- 56 US
- Distribution
- Domestic distribution US nationwide.
- Date initiated
- 2022-08-25
- Date posted
- 2022-10-05
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G7 ACETABULAR SYSTEM (K121874) | Biomet Manufacturing Corp | 2012-11-23 |