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
Product summary
- 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
Cutter was longer than was stated on the label