The Recall Desk
SevereFDA (Devices)·Z-2528-2019·Announced 2019-09-18

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

Zimmer Biomet is recalling 8 units of Vanguard XP Tibial Trays 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects in medical devices are classified as Severe.

Plain-English summary

Zimmer Biomet, Inc. is recalling 8 units of Vanguard XP Tibial Trays (63 mm, Item # 195245) due to a defect where the locking bar does not fully engage. The affected lots include 833140, 332580, 514890, 764300, 754440, 837720, 999580, 999590, 999570, 764290, 999610, 090060, and 090020.

The recall covers distribution across numerous U.S. states and international regions, including Korea, China, Canada, Australia, Japan, EMEA, Sweden, and Italy. The source text does not specify reported injuries or illnesses associated with this defect.

Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall. The FDA has classified this as a Class II recall.

The recalled product

Product
Vanguard XP Tibial Tray 63 mm Item # 195245
Affected units
8

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 →