Class II recallOngoing

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, recall — FDA event 97765

FDA · FDA event 97765 · Posted Nov 3, 2025

Published Nov 3, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, by Zimmer Biomet.

Products affected by FDA event 97765
Model	Description	Lot / serial range	Manufactured	Status
Z-0418-2026 · 110031012; semi constrained hip prosthesis	Z-0418-2026	UDI (01)00889024572706(17)300406(10)67160447; Lot Number 67160447	Not provided in the normalized record	Ongoing
Z-0419-2026 · 110031013; semi constrained hip prosthesis	Z-0419-2026	UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480	Not provided in the normalized record	Ongoing

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
Units affected: See official FDA record
Category: Hip implants

Timeline

Sep 26, 2025
Recall initiated
Date recorded by the FDA.
Nov 3, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 97765
Published: Nov 3, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, recall — FDA event 97765

FDA · FDA event 97765 · Posted Nov 3, 2025

Published Nov 3, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, by Zimmer Biomet.

Products affected by FDA event 97765
Model	Description	Lot / serial range	Manufactured	Status
Z-0418-2026 · 110031012; semi constrained hip prosthesis	Z-0418-2026	UDI (01)00889024572706(17)300406(10)67160447; Lot Number 67160447	Not provided in the normalized record	Ongoing
Z-0419-2026 · 110031013; semi constrained hip prosthesis	Z-0419-2026	UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480	Not provided in the normalized record	Ongoing

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

Units affected

See official FDA record

Persona Revision Trabecular Metal Femoral Distal Augment recall — FDA event 99073

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

FDA · FDA event 99073Posted Jun 24, 2026

Class II recallOngoing

Klassic BiPolar Head recall — FDA event 97708

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

FDA · FDA event 97708Posted Nov 5, 2025

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, recall — FDA event 97765

Follow Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, recall — FDA event 97765

Follow Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene,

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline