Synthes, Inc. recalls Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone sur…

Recall date

January 6, 2012

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1094-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

Distributed in the state of WI

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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