(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement p...
FDA Recall #Z-1042-2023 — Class II — December 29, 2022
Product Description
(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
Reason for Recall
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Recalling Firm
Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
157 units
Distribution
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
Code Information
(1) UDI: (01)00880304270770(17)320408(10)J7209534 Lot Number: J7209534 Expanded Recall: Lot Numbers/UDI: J7197497 (01)00880304270770(17)320504(10)J7197497, J7215873 (01)00880304270770(17)320428(10)J7215873, J7220365 (01)00880304270770(17)320504(10)J7220365, J7220368 (01)00880304270770(17)320504(10)J7220368. (2) Lot Numbers/UDI: J7133633 (01)00880304270787(17)320504(10)J7133633; J7175232 (01)00880304270787(17)320504(10)J7175232. (3) Lot Number/UDI: J7173881 (01)00880304270794(17)320504(10)J7173881; (4) Lot Number/UDI: J7220405 (01)00880304270080(17)320504(10)J7220405. (5) Lot Number /UDI: J7215860 (01)00880304270817(17)320505(10)J7215860.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated