Recall Z-1711-2015— Synthes, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes, Inc., initiated 2015-05-13, terminated 2016-08-18. FDA's recall record names no specific 510(k) clearance for this event. 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 washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.. Reason: affected parts and lots of the Cannulated Drill Bits have the potential to break during use.
- Recalling firm
- Synthes, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-13
- Terminated
- 2016-08-18
- Firm location
- West Chester, PA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.