The Recall Desk
SevereFDA (Devices)·Z-2536-2019·Announced 2019-09-18

Zimmer Biomet Recalls Vanguard XP Tibial Tray Due to Locking Bar Issue

Zimmer Biomet is recalling 49 units of Vanguard XP Tibial Tray 83 mm because the locking bar may not fully engage.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving structural defects in medical devices are assigned a severity score of 4 (Severe).

Plain-English summary

Zimmer Biomet, Inc. is recalling 49 units of the Vanguard XP Tibial Tray 83 mm (Item # 195253). 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 internationally to countries including Korea, China, Canada, Australia, Japan, and various European regions. Specific lot numbers are listed in the agency's official records.

Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall and replacement of the affected devices.

The recalled product

Product
Vanguard XP Tibial Tray 83 mm Item # 195253
Affected units
49

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 →