Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 50 units of the XP-XP Tibial Tray - Interlok 59 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 involves a structural defect in a medical device (locking bar not fully engaging) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 50 units of the XP-XP Tibial Tray - Interlok 59 mm (Item # 195750). The recall is due to a defect where the locking bar may not fully engage.
The affected units are distributed across numerous U.S. states and internationally in Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. Specific lot numbers involved include 206540, 057180, 206590, 206580, 206550, 030800, 206560, 457940, 457880, 457930, 457970, and 457950.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 59 mm Item # 195750
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 50
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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