Orthovita, Inc., dBA Stryker Orthobiologics. recalls Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when…

Recall date

February 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1353-2015

FDA classification

Class II

Brand / firm

Orthovita, Inc., dBA Stryker Orthobiologics.

Sold / distributed

Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.

Why it was recalled

Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.