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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