Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 480 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 involves a structural defect in a medical implant (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 where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 480 units of the XP-XP Tibial Tray - Interlok 63 mm (Item # 195751). The recall is being conducted because the locking bar on the device may not fully engage.
The affected products were distributed to facilities in 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 facilities in Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
Healthcare providers should stop using the affected devices and contact Zimmer Biomet for further instructions. Patients who have had these devices implanted should consult their healthcare provider regarding the recall.
The recalled product
- Product
- XP-XP Tibial Tray - Interlok 63 mm Item # 195751
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 480
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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