Class 2 Device Recall G7 Dual Mobility

• Date Initiated by Firm: February 06, 2023
• Date Posted: March 23, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1284-2023
• Recall Event ID: 91866
• 510(K)Number: K150522
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
• Code Information: UDI: (01)00880304703506(17)321128(10)65731960; Lot Number: 65731960
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer 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.
• FDA Determined 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 in Commerce: 12 units
• Distribution: US Distribution to states of: AZ, FL, GA, MI, NE, and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LPH and Original Applicant = BIOMET, INC.