Recall Z-2156-2020— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2020-04-17, terminated 2021-06-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 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
Product description
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 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.