device · product 1 of 2
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
- Recall number
- Z-1481-2022
- Initiated
- April 01, 2020
- Classification
- Class II
- Status
- Completed
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 3392
App-derived interpretation
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Official device-enrichment evidence · Sourced
Process change control
Inspect official wording and provenance
Reason for recall
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Code information
UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796.
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.