Aesculap Implant Systems LLC PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
UDI-DI: 04046955083374, lots M45041, M45399, M45711, M46069, M46350, M47462, M47893, M48115, M48279, M48346, M48467, M48596, M48753, M48848, M48907, M49375, M49435, M49632, M49683, M49711, M49867, M55796.
Products Sold
UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796.
Aesculap Implant Systems LLC is recalling PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-1 due to Endoscopic graspers may become separated at the weld from handle to the shaft of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026