The Recall Desk
HighFDA (Devices)·Z-2514-2019·Announced 2019-09-18

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

Zimmer Biomet is recalling 82 units of the XP-CR 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 device (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 criteria for a High severity score.

Plain-English summary

Zimmer Biomet, Inc. is recalling 82 units of the XP-CR Tibial Tray - Interlok 91 mm (Item # 195279). The recall is being conducted because the locking bar on the device may not fully engage.

The affected units were distributed across numerous U.S. states and internationally to Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. Specific lot numbers associated with this recall include 262480, 960510, 274400, 274430, 336060, 336060R, 274390, 274410, 279280, 394540, 394590, 394570, 821400, 903420, 960530, 422490, and 512590.

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 91 mm Item # 195279
Affected units
82

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 →