FDA-Device2014-02-05Class II

Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

The Anspach Effort, Inc.
Hazard

Cutter was longer than was stated on the label

Sold states
Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
Affected count
29 cutting burs
Manufactured in
4500 Riverside Drive, Palm Beach Gardens, FL, United States
Products
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0830-2014

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