Z-1482-2022 Class II
FDA device recall Z-1482-2022 was initiated by Aesculap Implant Systems LLC on April 1, 2020 and is designated Class II. Reason for recall: Endoscopic graspers may become separated at the weld from handle to the shaft of the device. Affected quantity: 399.
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2022
- Initiation Date
- April 1, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 399
Product Description
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Reason for Recall
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Distribution Pattern
United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.
Code Information
UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436.