Class 2 Device Recall Zimmer Biomet VivacitE

• Date Initiated by Firm: September 26, 2025
• Date Posted: November 03, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0419-2026
• Recall Event ID: 97765
• 510(K)Number: K190656
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
• Code Information: UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 411 Technical Services; 574-3713071
• Manufacturer Reason for Recall: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
• FDA Determined Cause: Labeling mix-ups
• Action: Zimmer Biomet issued an URGENT MEDICAL DEVICE recall notice to its consignees on 9/25/2025 via FedEx, 2nd Day Delivery. The notice explained the issue, potential risks, and requested the return of all affected devices in inventory. Risk Managers were notified that the sales representatives would be removing the affected products. Recommendation for patient monitoring was made to the implanting surgeons. For further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 a.m. and 5:00 p.m. EST, Monday through Friday. 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. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
• Quantity in Commerce: 63 units
• Distribution: US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS
• 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