Z-1711-2015 Class II Terminated

Recalled by Synthes, Inc. — West Chester, PA

Recall Details

Product Type
Devices
Report Date
June 10, 2015
Initiation Date
May 13, 2015
Termination Date
August 18, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1495 US (37 OUS)

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

Distribution Pattern

Worldwide Distribution - US (nationwide) and Canada.

Code Information

Part Number 310.65 310.67 310.221 lot numbers PE00966 PE01000 PE01039 PE01058 PE00959 PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971 PE01059 PE01040