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Recall Observatory FDA recall evidence

Device product

Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.

Z-1629-2014

December 03, 2013

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 68021
Status
Terminated
Classification
Class II
Quantity
150
Official record key
device-enforcement:Z-1629-2014

Official wording

Reason: The Irrigation Clips were assembled with the incorrect (smaller) clips.

Code information: Batch G323082757.

Distribution pattern: US Nationwide Distribution in the state of Mississippi.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Irrigation Clips were assembled with the incorrect (smaller) clips.