FDAClass IIFebruary 18, 2015

Hemostatic Bone Putty recall

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

Why was Hemostatic Bone Putty 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part 10847A

Product
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Recalling firm
Synthes, Inc.
Quantity
38
Distribution
Distributed in the state of WI
Recall date
February 18, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls