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.
FDA Recall Z-1353-2015 · Posted 2015-03-30
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Recalling FirmOrthovita, Inc., dBA Stryker Orthobiologics.
Recall StatusTerminated
Product CodeLMH
Date Initiated2015-02-26
Date Terminated2015-07-28
Product Quantity274
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.
Firm 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.
Root Cause
Storage
Distribution Pattern
Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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