Zimmer Biomet Recalls Vanguard XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 43 units of Vanguard XP Tibial Tray 65 mm 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 3/5 (High).
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 involves a structural defect (locking bar not fully engaging) in a medical device, which poses a risk of harm without reported fatalities or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 43 units of the Vanguard XP Tibial Tray 65 mm (Item # 195246). The recall was initiated because the locking bar on the device may not fully engage.
The affected units were distributed to 43 states and the District of Columbia in the United States, as well as to international locations including Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. Specific lot numbers associated with the recall include 833150, 332620, 514900, 752000, 372950, 752010, 919200, 837730, 764310, 764320, 884350, 883500, 968960, 968970, 968980, 754450, 883450, 584190, 861150, and 660380.
Healthcare providers and patients who have received this specific tibial tray should contact Zimmer Biomet for instructions on how to proceed. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Vanguard XP Tibial Tray 65 mm Item # 195246
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 43
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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