Zimmer Biomet Recalls Vanguard XP Tibial Trays Due to Locking Bar Issue
Zimmer Biomet is recalling 8 units of 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects in medical devices are classified as Severe.
Plain-English summary
Zimmer Biomet, Inc. is recalling 8 units of Vanguard XP Tibial Trays (63 mm, Item # 195245) due to a defect where the locking bar does not fully engage. The affected lots include 833140, 332580, 514890, 764300, 754440, 837720, 999580, 999590, 999570, 764290, 999610, 090060, and 090020.
The recall covers distribution across numerous U.S. states and international regions, including Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. The source text does not specify reported injuries or illnesses associated with this defect.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Vanguard XP Tibial Tray 63 mm Item # 195245
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 8
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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