Device product
(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 Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left; 62.5 mm. Item Number: 183126
Z-1043-2023
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 91489
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 91 units
- Official record key
device-enforcement:Z-1043-2023
Official wording
Reason: Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Code information: (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
Distribution pattern: 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
Derived failure modes
-
Labeling or packaging
Incorrectly labeled