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G7 Dual Mobility Acetabular System recallZ-1284-2023 · Biomet, Inc. · initiated Feb 6, 2023

Open, Classified

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 Biomet, 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 package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1284-2023
Status
Open, Classified
Initiated by the company
Feb 6, 2023
Posted by the FDA
Mar 23, 2023
Recalling firm
Biomet, Inc.
Quantity
12 units
Product code
LPH
FDA submissions
K150522
Distribution
US Distribution to states of: AZ, FL, GA, MI, NE, and TX.

Product description

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

Code information (models, lots, serial numbers)

UDI: (01)00880304703506(17)321128(10)65731960; Lot Number: 65731960

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

13 devices cleared under K150522 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

How recalls are matched to devices · Editorial policy · Report an error on this page