Z-1482-2022Class II

PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

Name: Z-1482-2022 PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Creator: Aesculap Implant Systems LLC
Published: 2020-04-01
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2020-04-01 / Completed / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10 on 2020-04-01. FDA classified it as Class II and gives the reason as "Endoscopic graspers may become separated at the weld from handle to the shaft of the device". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1482-2022
Classification: Class II
Status: Completed
Initiated: 2020-04-01
Posted: 2022-07-29
Recalling firm: Aesculap Inc
Product: PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Product code: KOA Surgical Instruments, G-U, Manual (And Accessories)
Reason for recall: Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1482-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1481-2022	Class II	Completed	Voluntary: Firm initiated	2022-08-10	2022-07-29
Z-1482-2022	Class II	Completed	Voluntary: Firm initiated	2022-08-10	2022-07-29

Product code KOA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)