The Recall Desk
HighFDA (Devices)·Z-2503-2019·Announced 2019-09-18

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

Zimmer Biomet is recalling 45 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. The hazard involves a mechanical defect in a medical device that could lead to injury, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Biomet, Inc. is recalling 45 units of the XP-CR Tibial Tray- Interlok 59mm (Item # 195268). The recall is due to a defect where the locking bar may not fully engage.

The affected units were distributed across numerous U.S. states and several international regions, including Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. Specific lot numbers associated with this recall include 004960, 262370, 130580, 004970, 130630, 130550, 130610, 130560, 130570, 004950, 130590, and 279210.

Healthcare providers and patients should check their inventory or medical records for these specific item and lot numbers. If the product is identified, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.

The recalled product

Product
XP- CR Tibial Tray- Interlok 59mm Item # 195268
Affected units
45

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 →