FDA Medical Device Recalls (openFDA)
Synthes, Inc.: Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
- Recall number
- Z-1094-2015
- Recalling firm
- Synthes, Inc.
- Product
- Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
- Status
- Terminated
- Initiated
- 2012-01-06
- Posted
- 2015-02-11
- Terminated
- 2015-03-30
- 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 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.
- Quantity
- 38
- Distribution
- Distributed in the state of WI
- Lot, serial or model codes
- Part 10847A
- 510(k) numbers
- ["K113079"]
- PMA numbers
- not on file
- Product code
- MTJ
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28