Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Ca
FDA device recall Z-0418-2026 · posted 2025-11-03 · Open, Classified
Recall details
- Recalling firm
- Zimmer, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- LPH
- Quantity affected
- 72 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
- Date initiated
- 2025-09-26
- Date posted
- 2025-11-03
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings (K190656) | Zimmer, Inc. | 2019-12-06 |