(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
Reported: February 8, 2023 Initiated: December 29, 2022 #Z-1043-2023
Product Description
(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
Reason for Recall
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 91 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
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
(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. Recalled by Biomet, Inc.. Units affected: 91 units.
Why was this product recalled? ▼
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2023. Severity: Moderate. Recall number: Z-1043-2023.
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