Reported Feb 18, 2015 · Terminated

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

Synthes, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417

Is this the product you have?

  • Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Lot codes and dates
  • Part 10847A
Amount recalled
38

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 30, 2015 · Data as of Sep 19, 6:50 PM UTC

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