Device product
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Z-0830-2014
Product summary
- Event
- Event 67176
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 cutting burs
- Official record key
device-enforcement:Z-0830-2014
Official wording
Reason: Cutter was longer than was stated on the label
Code information: Lot #'s: D323038131 and D343038845
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