FDA Device recall Z-2171-2015
1X1 Cleaving Tiles
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of 1X1 Cleaving Tiles by American Medical Systems Innovation Center Silicon Valley, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2171-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-28 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Medical Systems Innovation Center Silicon Valley |
| Distribution | US |
Product
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
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
Identifiers
| code_info | Model 80-10007-001; All product manufactured from April 8, 2012 to April 8, 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2171-2015%22
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