Device product
AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 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-2284-2016
Product summary
- Event
- Event 74563
- Status
- Terminated
- Classification
- Class II
- Quantity
- 471 units
- Official record key
device-enforcement:Z-2284-2016
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: ANC1549¿ ANC1612¿ ANC1678¿ ANC1679¿ ANC1682¿ ANC2001¿ ANC2008¿ ANC2009¿ ANC2013¿ ANC2015¿ ANC2016¿ ANC2017¿ ANC2018¿ ANC2019¿ ANC2020¿ ANC2021¿
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.