Aesculap Implant Systems LLC Recall 90493
Description: PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Aesculap Implant Systems LLC Recall 90493 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1482-2022 |
| Event ID | 90493 |
| Event Description | PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10 |
| Product Type | Devices |
| 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. |
| Quantity | 399 |
| Recall Reason | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| Device Classification | 20220810 |
| Device Code Info | UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436. |
| Center Classification Date | 20220729 |
| Recall Initiation Date | 20200401 |
| Recalling Firm | Aesculap Implant Systems LLC |
| Initial Notification | Letter |
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