Zimmer Biomet Recalls Dual Mobility Vivacit-E Bearing Due to Sizing Error
Zimmer Biomet is recalling 31 Dual Mobility Vivacit-E bearings because the outer package label indicates a different size than the implant inside.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding size, which is a significant quality control issue but does not involve a high-risk pathogen or structural defect leading to immediate severe injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 31 units of the Dual Mobility Vivacit-E Bearing, Model Number 110031009. The recall is due to a labeling discrepancy where the outer package is labeled as a Size C 38 mm, but the implant inside the package is a Size E 42 mm.
The affected products were distributed to healthcare facilities in the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV. The specific lot number for the recalled items is 64755636.
Healthcare providers should check their inventory for this specific model and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the recall instructions provided by Zimmer Biomet.
The recalled product
- Product
- Dual Mobility Vivacit-E Bearing, Model Number 110031009
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 31
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 (1)
- Lot Number 64755636
Distribution
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · mis labeling
See all →- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
Similar recalls
- HighHip bearings recalled because size F packages contain size G implants
FDA (Devices) · 2025-11-12
- HighSize G hip bearings recalled over commingled implant sizes in packaging
FDA (Devices) · 2025-11-12
- ModerateBiomet Recalls Active Articulation E1 Hip Bearing Implants Due to Labeling Errors
FDA (Devices) · 2013-06-12
- ModerateZimmer Biomet Recalls Vanguard Knee System Tibial Bearings Due to Labeling Error
FDA (Devices) · 2018-06-20
- ModerateZimmer Biomet Recalls Orthopedic Plates Due to Labeling Mismatch
FDA (Devices) · 2016-01-20
- HighZimmer Biomet Recalls Vanguard Knee Bearings Due to Packaging Mix-up
FDA (Devices) · 2018-07-04