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G7 Acetabular System recallZ-0007-2023 · Zimmer, Inc. · initiated Aug 25, 2022

Class II Open, Classified All recalls posted in October 2022

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected].

Recall details

Recall number
Z-0007-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 25, 2022
Posted by the FDA
Oct 5, 2022
Recalling firm
Zimmer, Inc.
Quantity
56 US
Product code
OQI
FDA submissions
K121874
Distribution
Domestic distribution US nationwide.

Product description

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

Code information (models, lots, 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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

60 devices cleared under K121874 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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