Home / Recalls / Medical Devices
Biomet, Inc. recalls (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number:
Recalled February 8, 2023 · FDA recall Z-1042-2023 · Biomet
Hazard
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). · FDA Class II
Units
157 units
Sold at
International distribution to the countries of: Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. Expanded Recall US states of: FL, IN, MD, OH, PA, WI
Description
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Product
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →