Synthes Recalls Bone Putty Over Ignition Concerns

Orthopedic device manufacturer Synthes has issued a voluntary Class I recall of its Hemostatic Bone Putty, according to an FDA news release.

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Hemostatic Bone Putty is designed to stop bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure.

Synthes has recalled all lots of the bone putty, citing potential for the product to ignite when in contact with electrosurgical cautery systems. The Class I category is the most serious type of recall since it can cause serious adverse events or death.

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