The Recall Desk
HighFDA (Devices)·Z-2504-2019·Announced 2019-09-18

Zimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Defect

Zimmer Biomet is recalling 322 units of XP-CR Tibial Trays 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 medical device with a functional defect (locking bar not fully engaging) which poses a risk of harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling 322 units of the XP-CR Tibial Tray - Interlok 63mm (Item # 195269). The recall was initiated because the locking bar on the device may not fully engage.

The affected devices 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 devices were also distributed internationally to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy.

Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the recall. The specific lot numbers affected are listed in the official recall documentation.

The recalled product

Product
XP-CR Tibial Tray - Interlok 63mm Item # 195269
Affected units
322

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.

See all 35 products in this recall →