Zimmer Biomet Recalls Vanguard XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 49 units of Vanguard XP Tibial Tray 83 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 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving structural defects in medical devices are assigned a severity score of 4 (Severe).
Plain-English summary
Zimmer Biomet, Inc. is recalling 49 units of the Vanguard XP Tibial Tray 83 mm (Item # 195253). The recall is due to a defect where the locking bar may not fully engage.
The affected units were distributed across numerous U.S. states and internationally to countries including Korea, China, Canada, Australia, Japan, and various European regions. Specific lot numbers are listed in the agency's official records.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall and replacement of the affected devices.
The recalled product
- Product
- Vanguard XP Tibial Tray 83 mm Item # 195253
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 49
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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