FDA Devices Moderate Class II Completed

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

Reported: August 10, 2022 Initiated: April 1, 2020 #Z-1482-2022

Product Description

Reason for Recall

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

Details

Recalling Firm: Aesculap Implant Systems LLC
Units Affected: 399
Distribution: 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.
Location: Center Valley, PA

Frequently Asked Questions

What product was recalled? ▼

PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10. Recalled by Aesculap Implant Systems LLC. Units affected: 399.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 10, 2022. Severity: Moderate. Recall number: Z-1482-2022.