—#196076

Product

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

FDA product code: OQI — Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K121874
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Domestic distribution US nationwide.

Timeline

Recall initiated: 2022-08-25
Posted by FDA: 2022-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196076. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.