Recall Z-1711-2015 ยท HTW Bit, Drill
Synthes, Inc.
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.
| Date | Jun 4, 2015 (initiated May 13, 2015) |
| Status | Terminated |
| Reason | affected parts and lots of the Cannulated Drill Bits have the potential to break during use |
| Root cause | Component design/selection |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have any of the identified devices, please take the following steps: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. " Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Retur |
| Quantity | 1495 US (37 OUS) |
| Distribution | Worldwide Distribution - US (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.