Recall Z-1410-2022— Aesculap Implant Systems LLC
Class II · Terminated
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2021-10-25, terminated 2024-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441. Reason: Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-25
- Terminated
- 2024-06-12
- Firm location
- Center Valley, PA, United States
Product description
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Reason for recall
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Data sourced from openFDA. This site is unofficial and independent of the FDA.