Zimmer Biomet Recalls Vanguard XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 123 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 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 involves a medical device with a functional defect (locking bar not fully engaging) that poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is recalling 123 units of the Vanguard XP Tibial Tray 69 mm (Item # 195248). The recall is being conducted because the locking bar on the device may not fully engage.
The affected units were distributed across numerous U.S. states and international locations, including Canada, Australia, Japan, and various European countries. The recall covers specific lot numbers, including 117720, 332660, and 373010.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or repair of these devices.
The recalled product
- Product
- Vanguard XP Tibial Tray 69 mm Item # 195248
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 123
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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