FDA Device recall Z-1043-2023
(1) Vanguard Knee System PS Open Box Femoral
- FDA Device
- Class II
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of (1) Vanguard Knee System PS Open Box Femoral by Biomet, citing components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1043-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-29 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | FL, IN, MD, OH, PA, WI |
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
Reason
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Identifiers
| code_info | (1) UDI: (01)00880304270862(17)320504(10)J7186089 Lot Number: J7186089. Expanded Recall: (2)UDI: (01)00880304270879(17…(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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1043-2023%22
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