PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
- Company
- Aesculap Implant Systems Llc
- Recall Initiated
- April 1, 2020
- Recall Number
- Z-1482-2022
- Quantity
- 399
- Firm Location
- Center Valley, PA
Reason for Recall
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
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.
Lot / Code Info
UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436.
Root Cause
Process change control
Action Taken
A notification letter was issued April 30, 2020 sent USPS Certified mail . The notification identifies the products as Catalog Item # 8360-10 PRESTIGE ATRA GRASPER DBL-ACT 5MM and 8361-10 PRESTIGE RETR GRASPER DBL-ACT 5MM. Customers were to evaluate inventory with a "tug test" and submit the notification acknowledgment form. Should a device fail the tug test, customers were to file a complaint using Aesculap's Online Customer Complaint Submission Form and return a the product. The products have since been discontinued.