Zimmer Biomet Recalls Mislabelled Vanguard CR Porous Femoral Knee Implants
Zimmer Biomet is recalling eight Vanguard CR Porous Femoral knee implants because they are labeled as 62.5mm Left Femurs but contain 70mm Right Femurs.
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 temporary or medically reversible adverse health consequence. The hazard is a labeling error (wrong size and side) rather than a material defect or contamination, fitting the Moderate severity criteria for labeling issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling eight units of the Vanguard CR Porous Femoral 62.5mm (Left Femur) implant, intended for use in total knee arthroplasty. The recall is due to a labeling error where the product packaging identifies the contents as a 62.5mm Left Femur, but the actual implant inside is a Vanguard 70mm Right Femur.
The affected products are identified by Item #183066 and Lot 132900. The Universal Device Identifier (UDI) is (01) 0088030427068 (17) 270816 (10) 132900. These units were distributed in the United States to the states of Florida, Wisconsin, Maryland, Missouri, and Michigan.
Healthcare providers and patients should verify the specific size and laterality of the implanted device against the surgical records and the physical implant. If a device matching the description above has been implanted, providers should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 8
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)
- Item #183066/Lot 132900
- UDI-(01) 0088030427068 (17) 270816 (10) 132900
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 →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 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
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateZimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch
FDA (Devices) · 2018-11-28
- ModerateZimmer Biomet Recalls Vanguard Distal Femoral Augments Due to Labeling Error
FDA (Devices) · 2016-10-26
- ModerateZimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error
FDA (Devices) · 2018-02-28
- ModerateZimmer Biomet Recalls Vanguard Total Knee System Femoral Components Due to Labeling Errors
FDA (Devices) · 2017-02-08
- ModerateZimmer Biomet Recalls Vanguard Knee Patella Implants Due to Labeling Mismatch
FDA (Devices) · 2019-03-06
- ModerateZimmer Biomet Recalls Vanguard Knee System Patella Components Due to Labeling Error
FDA (Devices) · 2019-03-06