Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
This recall has been terminated (originally issued February 11, 2015).
- Company
- Synthes, Inc.
- Recall Initiated
- January 6, 2012
- Posted
- February 11, 2015
- Terminated
- March 30, 2015
- Recall Number
- Z-1094-2015
- Quantity
- 38
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed in the state of WI
Lot / Code Info
Part 10847A
Root Cause
Labeling mix-ups
Action Taken
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 a surgeon. On 01/06/2012, the sales consultant spoke to the surgeon in person and the surgeon confirmed that he had disposed of the Rev. A.