FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
- Recall number
- Z-1481-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
- Status
- Completed
- Initiated
- 2020-04-01
- Posted
- not on file
- Terminated
- not on file
- 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
- 3392
- 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, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KOA
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28