Recall Z-1353-2015— Orthovita, Inc., dBA Stryker Orthobiologics.
Class II · Terminated
Class II FDA medical device recall by Orthovita, Inc., dBA Stryker Orthobiologics., initiated 2015-02-26, terminated 2015-07-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-26
- Terminated
- 2015-07-28
- Firm location
- Malvern, PA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.