Biomet, Inc.: (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Fem

Hazard

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

Details from the source

Reason for recall: Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). 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 Quantity: 91 units Lot/code info: (1) UDI: (01)00880304270862(17)320504(10)J7186089 Lot Number: J7186089. Expanded Recall: (2)UDI: (01)00880304270879(17)320504(10)J7173870 Lot Number: J7173870. (3) UDI: (01)00880304270893(17)320504(10)J7192119; (01)00880304270893(17)320504(10)J7197508; (01)00880304270893(17)320504(10)J7209606; (01)00880304270893(17)320504(10)J7220427; Lot Numbers: J7192119, J7197508, J7209606, J7220427

UPC codes

00880304270862, 00880304270879, 00880304270893

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.