Device product
Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
Z-2285-2016
Product summary
- Event
- Event 74563
- Status
- Terminated
- Classification
- Class II
- Quantity
- 170 units
- Official record key
device-enforcement:Z-2285-2016
Official wording
Reason: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
Code information: Lot Numbers: ANC1487¿ ANC1665¿ ANC1672¿ ANC1683¿ ANC2002¿ ANC2003¿ ANC2010¿ ANC2011¿
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.