FDA Medical Device Recalls (openFDA)
Biomet, Inc.: G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
- Recall number
- Z-1284-2023
- Recalling firm
- Biomet, Inc.
- Product
- G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
- Status
- Open, Classified
- Initiated
- 2023-02-06
- Posted
- 2023-03-23
- Terminated
- not on file
- Reason
- 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
- 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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: CorporateQuality.PostMarket@zimmerbiomet.com. 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
- 12 units
- Distribution
- US Distribution to states of: AZ, FL, GA, MI, NE, and TX.
- Lot, serial or model codes
- UDI: (01)00880304703506(17)321128(10)65731960; Lot Number: 65731960
- 510(k) numbers
- ["K150522"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28