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U.S. Department of Health and Human Services

Class 2 Device Recall Vitagel

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  Class 2 Device Recall Vitagel see related information
Date Initiated by Firm February 26, 2015
Date Posted March 30, 2015
Recall Status1 Terminated 3 on July 28, 2015
Recall Number Z-1353-2015
Recall Event ID 70609
PMA Number P050044 
Product Classification Implant, dermal, for aesthetic use - Product Code LMH
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.
Code Information Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076; Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016 
Recalling Firm/
Manufacturer		 Orthovita, Inc., dBA Stryker Orthobiologics.
45 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Customer Support
610-640-1775
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 274
Distribution Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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