PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 10, 2015 Initiated: May 13, 2015 #Z-1711-2015

Product Description

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.

Reason for Recall

affected parts and lots of the Cannulated Drill Bits have the potential to break during use

Details

Recalling Firm
Synthes, Inc.
Units Affected
1495 US (37 OUS)
Distribution
Worldwide Distribution - US (nationwide) and Canada.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Synthes, Inc.. Units affected: 1495 US (37 OUS).
Why was this product recalled?
affected parts and lots of the Cannulated Drill Bits have the potential to break during use
Which agency issued this recall?
This recall was issued by the FDA Devices on June 10, 2015. Severity: Moderate. Recall number: Z-1711-2015.