The Recall Desk
HighFDA (Devices)·Z-2509-2019·Announced 2019-09-18

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

Zimmer Biomet is recalling 327 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 (locking bar not fully engaging) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Zimmer Biomet, Inc. is recalling 327 units of the XP-CR Tibial Tray - Interlok 73mm (Item # 195274). The recall was initiated because the locking bar on these devices may not fully engage.

The affected units were distributed across numerous US states, including New York, Indiana, Ohio, and California, as well as internationally to countries such as Korea, China, Canada, and Australia. Specific lot numbers are listed in the official recall documentation.

Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or return of these devices. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
XP-CR Tibial Tray - Interlok 73mm Item # 195274
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
327

Distribution

Distributed in 44 states:

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 →

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