Device product
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Z-1094-2015
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 70055
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38
- Official record key
device-enforcement:Z-1094-2015
Official wording
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.
Code information: Part 10847A
Distribution pattern: Distributed in the state of WI
Derived failure modes
-
Unknown
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.