Home / Recalls / American Medical Systems Innovation Center - Silicon Valley / Z-2171-2015

Z-2171-2015 Class II Terminated

Recalled by American Medical Systems Innovation Center - Silicon Valley — San Jose, CA

Recall Details

Product Type
Devices
Report Date
July 29, 2015
Initiation Date
May 28, 2015
Termination Date
January 19, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,710 total all affected devices

Product Description

1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.

Reason for Recall

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

Distribution Pattern

Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.

Code Information

Model 80-10007-001; All product manufactured from April 8, 2012 to April 8, 2015

Other recalls by American Medical Systems Innovation Center - Silicon Valley

  • Z-2167-2015 Class II — Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided fo (May 28, 2015)
  • Z-2177-2015 Class II — Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provide (May 28, 2015)
  • Z-2174-2015 Class II — Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool prov (May 28, 2015)
  • Z-2182-2015 Class II — Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool prov (May 28, 2015)
  • Z-2161-2015 Class II — Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended (May 28, 2015)
  • Z-2179-2015 Class II — Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provide (May 28, 2015)
  • Z-2186-2015 Class II — Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool prov (May 28, 2015)
  • Z-2172-2015 Class II — Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool prov (May 28, 2015)
  • Z-2187-2015 Class II — Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool prov (May 28, 2015)
  • Z-2180-2015 Class II — Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool prov (May 28, 2015)