Z-1284-2023Class II

G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

Name: Z-1284-2023 G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Creator: Biomet, Inc.
Published: 2023-02-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2023-02-06 / Open, Classified / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462 on 2023-02-06. FDA classified it as Class II and gives the reason as "The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1284-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-06
Posted: 2023-03-23
Recalling firm: Zimmer GmbH
Product: G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An "URGENT MEDICAL DEVICE RECALL" notification letter dated 2/6/23 was sent to customers. The customers were instructed to do the following: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form for each return and send to [email protected]. This form must be returned even if you do not have affected products available to return in your territory. b. Include a hardcopy of the completed form in each carton of your return shipment for immediate processing. c. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall. b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 6. 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 or email: [email protected]. 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.
Quantity in commerce: 12 units
Distribution: US Distribution to states of: AZ, FL, GA, MI, NE, and TX.
Product codes and lots: UDI: (01)00880304703506(17)321128(10)65731960; Lot Number: 65731960

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1284-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1284-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-23

Product code LPH

K150522Class IIG7 Dual Mobility SystemBiomet, Inc. / cleared 2015-05-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)