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

Recalled April 8, 2015 · FDA recall Z-1353-2015 · Orthovita, Inc.,

Hazard

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. · FDA Class II

Units

274

Sold at

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

Description

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.

Product

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.

Manufacturer(s)

Orthovita, Inc., dBA Stryker Orthobiologics.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →