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FDA Recalls Bone Putty for Risk of Igniting

Baisha Kreuzer4 years ago

A Class 1 recall has been made for the product Synthes Hemostatic Bone Putty due to a potential hazard of igniting if contacted with electrosurgical cautery systems while under certain surgery settings. This is a serious offense as a Class 1 recall is considered the highest alert by the FDA for medical products.

About the Bone Putty Recall

  • Hemostatic Bone Putty is used to discontinue bone bleeding by being inserted as a physical barrier along the edges of the bones that have been impaired by either surgery or trauma.
  • The affected lot numbers can be found on the FDA recall website.
  • The Hemostatic Bone Putty has a high potential of igniting if a connection with electrosurgical cautery under certain surgical conditions is made.

Synthes issued a Medical Device Recall letter on July 5, 2012, entreating medical facilities to check their inventory and immediately stop any use of parts identical to the lot numbers of the Hemostatic Bone Putty.

For more information regarding the recall, visit this website.

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