Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 1,221 units of the XP-XP Tibial Tray 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 the defect involves a structural component (locking bar) that could lead to device failure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,221 units of the XP-XP Tibial Tray - Interlok 71 mm (Item # 195755). The recall is due to a defect where the locking bar may not fully engage.
The affected devices were distributed across numerous US states and several international regions, including Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. The recall covers a wide range of specific lot numbers.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer Biomet for instructions on how to proceed.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 71 mm Item # 195755
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,221
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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