FDA Device recall Z-1094-2015
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces
- FDA Device
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces by Synthes, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1094-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-01-06 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | WI |
Product
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
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.
Identifiers
| code_info | Part 10847A |
|---|
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-1094-2015%22
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