Recall Z-1482-2022 ยท KOA Surgical Instruments, G-U, Manual (And Accessories)
Aesculap Implant Systems LLC
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
| Date | Apr 1, 2020 |
| Status | Completed |
| Reason | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.