Recall Z-2153-2020— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2020-04-17, terminated 2021-06-25. It names one FDA 510(k) clearance: K023546. Product: Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis. Reason: Potential presence of elevated endotoxin levels that exceed the specification limit.
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-17
- Terminated
- 2021-06-25
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis
Reason for recall
Potential presence of elevated endotoxin levels that exceed the specification limit
Data sourced from openFDA. This site is unofficial and independent of the FDA.