FDA-Device2015-02-18Class II

Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Synthes, Inc.
Hazard

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.

Sold states
Distributed in the state of WI
Affected count
38
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1094-2015

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