—#216540

Product

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K190656
Affected lot / code info: UDI (01)00889024572706(17)300406(10)67160447; Lot Number 67160447

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2025-09-26
Posted by FDA: 2025-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216540. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.