Synthes Hemostatic Bone Putty Recalled due to Ignition Risk

The FDA informs Risk Managers and Surgery healthcare personnel that Synthes Hemostatic Bone Putty is recalled because there is a risk of ignition under certain conditions during surgery.

Background of Synthes Hemostatic Bone Putty

Hemostatic Bone Putty, by Synthes USA HQ, Inc., is used to stop bone bleeding by creating a barrier along the damaged edges of the bones. Bones can be damaged during surgical operation or trauma. FDA Alert on Synthes Hemostatic Bone Putty

FDA’s reason for the recall is that Synthes Hemostatic Bone Putty can potentially ignite if contacted with electrosurgical cautery systems in surgery.

The affected part numbers are:

• 08.901.001.97S
• 08.901.001.98S
• 08.901.001.99S
• 08.901.001D
• VB1025.10S

The affected product manufacturing dates were from July 6, 2011 to December 14, 2011 and the distribution dates were from December 22, 2011 to June 25, 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Synthes Hemostatic Bone Putty

“On July 5, 2012, Synthes issued a Medical Device Recall letter requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the Hemostatic Bone Putty.

If a facility had the affected product in stock, they were asked to call 1-800-479-6329 to obtain a Return Authorization Number, complete the verification form and return both the form and identified product to Synthes.”

Contacting the FDA to report cases with Synthes Hemostatic Bone Putty

In case of detection of adverse events or side effects related to the use of Synthes Hemostatic Bone Putty, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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