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Vivacit-E recallZ-0419-2026 · Zimmer, Inc. · initiated Sep 26, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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 [email protected].

Recall details

Recall number
Z-0419-2026
Status
Open, Classified
Initiated by the company
Sep 26, 2025
Posted by the FDA
Nov 3, 2025
Recalling firm
Zimmer, Inc.
Quantity
63 units
Product code
LPH
FDA submissions
K190656
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

Product description

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 (models, lots, serial numbers)

UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

16 devices cleared under K190656 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97765).

Sources and updates

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