Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 90 units of the XP-XP Tibial Tray because the locking bar may not fully engage.
What this means for you
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 hazard involves a mechanical defect in a medical implant where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 90 units of the XP-XP Tibial Tray - Interlok 87 mm (Item # 195760). The recall was initiated because the locking bar on the device may not fully engage.
The affected units were distributed across numerous U.S. states, including New York, Indiana, Ohio, Michigan, Georgia, South Carolina, Florida, Missouri, Wisconsin, Minnesota, North Dakota, South Dakota, Nebraska, New Jersey, Pennsylvania, Maryland, Illinois, Iowa, California, Virginia, North Carolina, Washington D.C., West Virginia, Arkansas, Alabama, Mississippi, Washington, Oregon, Idaho, Louisiana, Kansas, Tennessee, Massachusetts, Kentucky, Oklahoma, Texas, Connecticut, Arizona, Nevada, New Mexico, Montana, and Wyoming. The products were also distributed to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 87 mm Item # 195760
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 90
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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