Synthes Cannulated Drill Bits Recalled for Potential Breakage During Use

Plain-English summary

Synthes, Inc. is recalling specific lots of 3.2 mm, 2.7 mm, and 2.0 mm Cannulated Drill Bits. The recall is due to a defect where the affected parts and lots have the potential to break during use. These drill bits are used with the Synthes Cannulated Screw, which is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.

The recall involves 1,495 units in the United States and 37 units outside the US. The affected devices were distributed nationwide in the US and in Canada. Specific part numbers and lot numbers are listed in the agency's recall record.

Healthcare providers and facilities that have received these devices should stop using them and contact Synthes, Inc. for instructions on how to return the affected units.

The recalled product

Product

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 wa

Manufacturer

Synthes, Inc.

Category

Medical Device — Orthopedic Instrument

Hazard

• structural-failure

Distribution

Related recalls