FDA-Device2015-06-10Class II
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
Synthes, Inc.
Hazard
affected parts and lots of the Cannulated Drill Bits have the potential to break during use
Sold states
Worldwide Distribution - US (nationwide) and Canada.
Affected count
1495 US (37 OUS)
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1711-2015Don't want to check this manually?
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