Recall Z-1481-2022— Aesculap Implant Systems LLC
Class II · Completed
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2020-04-01. FDA's recall record names no specific 510(k) clearance for this event. Product: PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10. Reason: Endoscopic graspers may become separated at the weld from handle to the shaft of the device..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2020-04-01
- Firm location
- Center Valley, PA, United States
Product description
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Reason for recall
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.