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Alert! FDA Issues Class I Recall on Synthes Hemostatic Bone Putty

FDA Recall

On Aug. 21, 2012, the US Food and Drug Administration (FDA) issued a Class I recall for Synthes Hemostatic Bone Putty.  There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions.
 
Hemostatic Bone Putty stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during surgical procedures.
 

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The affected Hemostatic Bone Putty was manufactured from July 6, 2011, to December 14, 2011, and distributed from December 22, 2011, to June 25, 2012.  The affected product includes all lots of the following product numbers:

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

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.  Facilities that have the affected product in stock should 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.

Any adverse reactions or problems experienced with the use of this product can be reported through the FDA's MedWatch Program or by phone at 1-800-FDA-1088

  • View the FDA Recall Notice for Synthes Hemostatic Bone Putty
  • Synthes, Inc. Customer Service: 1-800-523-0322
  • Synthes, Inc. USA Headquarters: 1-610-719-5450
© 2016 American Society for Surgery of the Hand

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