Zimmer Biomet Recalls Vanguard XP Tibial Trays Due to Locking Bar Issue
Zimmer Biomet is recalling Vanguard XP Tibial Trays because the locking bar may not fully engage. The recall covers units distributed in the US and internationally.
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: The recall is classified as FDA Class II. The hazard involves a mechanical failure (locking bar not fully engaging) in an implanted medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling Vanguard XP Tibial Tray 71 mm (Item # 195249) because the locking bar may not fully engage. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recall includes specific lot numbers and units distributed across numerous US 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, Wyoming, Colorado, and Utah. The product was also distributed to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
Healthcare providers and patients should contact Zimmer Biomet for further information regarding the recall and potential replacement or repair options. Patients who have had this specific tibial tray implanted should consult with their orthopedic surgeon to discuss the implications of the locking bar issue.
The recalled product
- Product
- Vanguard XP Tibial Tray 71 mm Item # 195249
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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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