FDA Device recall Z-1711-2015
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 f…
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of 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 f… by Synthes, citing affected parts and lots of the Cannulated Drill Bits have the potential to break during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1711-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-13 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
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
Identifiers
| code_info | Part Number 310.65 310.67 310.221 lot numbers PE00966 PE01000 PE01039 PE01058 PE00959 PE00968 PE0097…Part Number 310.65 310.67 310.221 lot numbers PE00966 PE01000 PE01039 PE01058 PE00959 PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971 PE01059 PE01040 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1711-2015%22
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