The Recall Desk
HighFDA (Devices)·Z-2512-2019·Announced 2019-09-18

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

Zimmer Biomet is recalling 180 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 is classified as FDA Class II, and the source text describes a mechanical defect (locking bar not fully engaging) in a medical device without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zimmer Biomet, Inc. is recalling 180 units of the XP-CR Tibial Tray - Interlok 83 mm (Item # 195277). The recall was initiated because the locking bar on the device may not fully engage.

The affected products 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.

The recall includes specific lot numbers: 141540, 513160, 571080, 262460, 938230, 938260, 966800, 996040, 066250, 283280, 663860, 851390, 663860R, 090260, 279290, 376610, 851380, 663890, 206880, 374840, 429310, 723100, 434300, 469560, 469560R, 162000, 258130, 043950, 320350, 320330, 076100, 279070, 600830, 672690, 599180, 374130, 576070, 952400, 450390, 712610, 717220, 943430, 141520, 279280, 376570, 376590, and 513140. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.

The recalled product

Product
XP-CR Tibial Tray - Interlok 83 mm Item # 195277
Affected units
180

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 →