Dual Mobility Vivacit-E Bearing (Zimmer) – packaging mix-up (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Zimmer, Inc.
Lot Codes / Batch Numbers
UDI (01)00889024572706(17)300406(10)67160447, Lot Number 67160447
Products Sold
UDI (01)00889024572706(17)300406(10)67160447; Lot Number 67160447
Zimmer, Inc. is recalling Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size due to 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 l. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, FL, GA, IL, IA, KS, MD, MI, NE, NM, NY, NC, OH, PA, TN, TX, WA, WI
Page updated: Jan 10, 2026