Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue
Zimmer Biomet is recalling 1,282 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 1,282 units of the XP-XP Tibial Tray - Interlok 69 mm (Item # 195754). The recall is due to a defect where the locking bar may not fully engage.
The affected devices were distributed across numerous US 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 devices were also distributed to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.
Consumers and healthcare providers 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 69 mm Item # 195754
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,282
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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