Z-0007-2023Class II

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

Name: Z-0007-2023 G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G)...
Creator: Zimmer, Inc.
Published: 2022-08-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2022-08-25 / Open, Classified / root cause: packaging

FDA source

Zimmer, Inc. began a recall of G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty on 2022-08-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0007-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-25
Posted: 2022-10-05
Recalling firm: Zimmer GmbH
Product: G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Product code: OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
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.
Root cause tag: packaging
FDA root cause: 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 [email protected].
Quantity in commerce: 56 US
Distribution: Domestic distribution US nationwide.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0007-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0007-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-10-05

Product code OQI

K121874Class IIG7 Acetabular SystemBiomet Manufacturing Corp / cleared 2012-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)