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.
What this means for you
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.
- 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
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 →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
Same hazard · component mismatch
See all →- ModerateMAMMOMAT Fusion system recalled because an operator table shipped with a bus-installation kit
FDA (Devices) · 2025-12-10
- ModerateMAMMOMAT Revelation systems recalled because operator tables shipped with bus-installation kits
FDA (Devices) · 2025-12-10
- ModerateMAMMOMAT Inspiration systems recalled because operator tables shipped with bus-installation kits
FDA (Devices) · 2025-12-10
- HighHip bearings recalled because size F packages contain size G implants
FDA (Devices) · 2025-11-12
- HighDental implant screws recalled because the wrong screw was packaged
FDA (Devices) · 2025-11-12