Recall Z-1094-2015 ยท MTJ Wax, Bone
Synthes, Inc.
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
| Date | Feb 11, 2015 (initiated Jan 6, 2012) |
| Status | Terminated |
| Reason | Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement. |
| Root cause | Labeling mix-ups |
| Action | On/about 12/22/2011, emails containing Revision B brochure, as well as instructions to delete/destroy Revision A, were sent to 38 affected individuals (sales consultants). On/about 1/04/2012, follow up phone calls were made to each member of the sales force who had received Rev. A (110847 A) to confirm that they had replaced the Rev. A with the Rev. B (110847 B). In addition, the members of the sales force were asked whether or not the Rev. A had been disseminated to any HCP's. During the follow up conversation, one member of the sales force stated that he had provided the previous version to |
| Quantity | 38 |
| Distribution | Distributed in the state of WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113079 | SYNTHES HEMOSTATIC BONE PUTTY Synthes (Usa) Products, LLC/Norian Corporation, Dec 13, 2011 |