Z-0419-2026Class II

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G...

Name: Z-0419-2026 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G...
Creator: Zimmer, Inc.
Published: 2025-09-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2025-09-26 / Open, Classified / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of 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... on 2025-09-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0419-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-26
Posted: 2025-11-03
Recalling firm: Zimmer GmbH
Product: 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
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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].
Quantity in commerce: 63 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
Product codes and lots: UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0419-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0418-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-03
Z-0419-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-03

Product code LPH

K190656Class IIDual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc. / cleared 2019-12-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)