Zimmer Biomet Recalls Vanguard XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 84 units of Vanguard XP Tibial Tray 73 mm because the locking bar may not fully engage.
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, and the defect involves a mechanical failure (locking bar not fully engaging) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 84 units of the Vanguard XP Tibial Tray 73 mm (Item # 195250). The recall was initiated because the locking bar on the device may not fully engage.
The affected units were distributed across 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 products were also distributed to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
The recall involves specific lot numbers, including 590540, 590530, 590520, 663190, 590550, 663200, 907710, 117740, 332690, 833210, 752580, 373050, 373060, 515050, 752120, 515070, 752100, 752110, 754490, 764390, 861210, 837790, 936210, 764400, 846520, 928890, 907690, 936220, 936230, 954050, 928880, 936200, 954030, 907700, 063000, 062990, 570980, and 584230. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Vanguard XP Tibial Tray 73 mm Item # 195250
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 84
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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