Zimmer Biomet Recalls Vanguard XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling Vanguard XP Tibial Trays because the locking bar may not fully engage.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for medical devices with potential for serious injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling Vanguard XP Tibial Tray 87 mm (Item # 195254) because the locking bar may not fully engage. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected product was distributed to facilities in numerous U.S. states, including New York, Indiana, Ohio, Michigan, Georgia, South Carolina, Florida, Missouri, Wisconsin, Minnesota, North Dakota, South Dakota, Nebraska, New Jersey, Pennsylvania, Maryland, Illinois, Iowa, California, Virginia, North Carolina, Washington D.C., West Virginia, Arkansas, Alabama, Mississippi, Washington, Oregon, Idaho, Louisiana, Kansas, Tennessee, Massachusetts, Kentucky, Oklahoma, Texas, Connecticut, Arizona, Nevada, New Mexico, Montana, and Wyoming. The product was also distributed to facilities in Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or repair of the device.
The recalled product
- Product
- Vanguard XP Tibial Tray 87 mm Item # 195254
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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)
- None distributed
Distribution
Part of a larger recall action
This product is one of 35 recalled by Zimmer Biomet, 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.
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