The U.S. Food and Drug Administration (FDA) announced that the firm Synthes USA, Inc. began a class I recall of its hemostatic bone putty device on July 5, 2012. The putty was recalled because it has the potential to ignite if touched by electrosurgical cautery systems during surgery.
The recall letter asked facilities to immediately check their inventory and stop using any recalled items. All lots of the following models are being recalled: 08.901.001.97S; 08.901.001.98S; 08.901.001.99S; 08.901.001D; and VB1025.10S.
The putty was manufactured between July 6, 2011 and Dec. 14, 2011. It was distributed from Dec. 22, 2011 to June 25, 2012.
Class I recalls are the most serious types of recalls by manufacturers, according to FDA guidelines. Products in this class that are recalled have a reasonable probability of causing severe health damage or death.
Hemostatic bone putty is used to stop bleeding along the edges of bones that have been damaged by trauma or cut during surgery. The putty establishes a physical barrier along the edges of the bones.
Facilities that have the listed numbers in stock are asked to request a Return Authorization Number, complete the verification form, and return the form and the product to Synthes. Even facilities that do not have the devices in stock are being asked to fill out and return the verification form to Synthes, saying that they received the Medical Device Letter regarding the recall.
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