Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when

FDA device recall Z-1353-2015 · posted 2015-03-30 · Terminated

Recall details

Recalling firm

Orthovita, Inc., dBA Stryker Orthobiologics.

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.

Action taken

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

Status

Terminated

Product code

LMH

Quantity affected

274

Distribution

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

Date initiated

2015-02-26

Date posted

2015-03-30

Date terminated

2015-07-28

Location

Malvern, PA