Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Reported: February 18, 2015 Initiated: January 6, 2012 #Z-1094-2015
Product Description
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Reason for Recall
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.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 38
- Distribution
- Distributed in the state of WI
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.. Recalled by Synthes, Inc.. Units affected: 38.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1094-2015.
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