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Completed

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

FDA Recall Z-1482-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusCompleted
Product CodeKOA
Date Initiated2020-04-01
Product Quantity399

Reason for Recall

Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

Firm 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.

Root Cause

Process change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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