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Recall Observatory FDA recall evidence

Device product

PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

Z-1482-2022

April 01, 2020

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 90493
Status
Completed
Classification
Class II
Quantity
399
Official record key
device-enforcement:Z-1482-2022

Official wording

Reason: Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

Code information: UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Endoscopic graspers may become separated at the weld from handle to the shaft of the device.