Recalls / —

—#199076

Product

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

FDA product code

LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K150522

Affected lot / code info

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

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Biomet, Inc.

Address

56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern

US Distribution to states of: AZ, FL, GA, MI, NE, and TX.

Timeline

Recall initiated

2023-02-06

Posted by FDA

2023-03-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #199076. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.