Agency classClass IIOur severity:High FDA (Devices)·Z-0419-2026·Announced 2025-11-12

Size G hip bearings recalled over commingled implant sizes in packaging

Zimmer is recalling 63 Dual Mobility Vivacit-E bearings labelled Size G 46 mm because the package contents and label may be commingled with the Size F 44 mm bearing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: an implant whose package states the wrong size can be selected and placed in the patient, and no injuries are reported.

Plain-English summary

The Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene Bearing, 28 mm I.D., 46 mm O.D., Size G, catalog number 110031013, a semi-constrained hip prosthesis component, is being recalled.

Zimmer Biomet is recalling two 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.

The recall covers 63 units from lot 67160447, carrying UDI 00889024572713, distributed in Ohio, Georgia, Wisconsin, Nebraska, Iowa, Illinois, California, New York, Maryland, North Carolina, Pennsylvania, Alabama, Tennessee, Michigan, Washington, Florida, Texas, Kansas, New Mexico and Arizona, and to Canada and Australia. The FDA has classified the action as Class II.

The enforcement record describes the size mismatch and reports no injuries. Facilities should quarantine affected lots and follow Zimmer's instructions.

The recalled product

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
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic implant
Hazard: component-mismatch
mislabeled-size
implant
packaging-error
Affected units: 63

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 20 states:

Part of a larger recall action

This product is one of 2 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Zimmer, Inc.

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Same hazard · component mismatch