Recall Z-1353-2015 ยท LMH Implant, Dermal, For Aesthetic Use
Orthovita, Inc., dBA Stryker Orthobiologics.
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.
| Date | Mar 30, 2015 (initiated Feb 26, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Storage |
| Action | Orthovita, Inc., dBA Stryker Orthobiiologics made phone notifications in February 2015 to all affected customers. Customers were told that the Vitagel they ordered on x date has an internal procedural mandate that says they must deliver in 35 hours and it has now passed that window. As a precaution until we can confirm that Vitagel delivered after shipping for longer is safe for use we are asking that they quarantine the order in question in the event the delivery occurs. For questions regarding this recall call 610-640-1775. |
| Quantity | 274 |
| Distribution | Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.