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Recall Observatory FDA recall evidence

Device product

AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

Z-0829-2014

March 31, 2011

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 67176
Status
Terminated
Classification
Class II
Quantity
599 cutting burs
Official record key
device-enforcement:Z-0829-2014

Official wording

Reason: Cutter was longer than was stated on the label

Code information: Lot #'s: D293037349, D323038110 and D363039140

Distribution pattern: Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cutter was longer than was stated on the label