Z-2170-2015Class II

Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber...

Name: Z-2170-2015 Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber...
Creator: American Medical Systems Innovation Center - Silicon Valley
Published: 2015-05-28
License: https://open.fda.gov/license/

American Medical Systems Innovation Center - Silicon Valley / initiated 2015-05-28 / Terminated / root cause: labeling and UDI

FDA source

American Medical Systems Innovation Center - Silicon Valley began a recall of Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizable tool used to... on 2015-05-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2170-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-28
Posted: 2015-07-21
Terminated: 2016-01-19
Recalling firm: American Medical Systems Innovation Center - Silicon Valley
Product: Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) 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.
Product code: GEX Powered Laser Surgical Instrument
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
Root cause tag: labeling and UDI
FDA root cause: Reprocessing Controls
Action: Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Quantity in commerce: 16,710 total all affected devices
Distribution: 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.
Product codes and lots: Model 0010-0760; All product manufactured from April 8, 2012 to April 8, 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2170-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2156-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2157-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2158-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2159-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2160-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2161-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2162-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2163-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2164-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2165-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2166-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2167-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2168-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2169-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2170-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2171-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2172-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2173-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2174-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2175-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2176-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2177-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2178-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2179-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2180-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2181-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2182-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2183-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2184-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2185-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2186-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2187-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21

Product code GEX

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)