Reported Aug 10, 2022 · Completed

PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

Aesculap Implant Systems LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217

Is this the product you have?

  • PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Lot codes and dates
  • 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
Amount recalled
3392

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Aesculap Implant Systems LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.