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U.S. Department of Health and Human Services

Class 2 Device Recall Aliquot Delivery Kit (Syringe and Plunger)

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  Class 2 Device Recall Aliquot Delivery Kit (Syringe and Plunger) see related information
Date Initiated by Firm August 20, 2015
Date Posted September 16, 2015
Recall Status1 Terminated 3 on March 10, 2017
Recall Number Z-2772-2015
Recall Event ID 72054
Product Classification Dispenser, cement - Product Code KIH
Product Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Code Information All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505   
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		 Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
FDA Determined
Cause 2		 Under Investigation by firm
Action Stryker Sent an Urgent Product Recall letter dated August 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer/User: Our records indicate that you have received the above referenced instruments. It is Stryker Orthobiologics responsibility as the manufacturer to ensure that customers who may have received these affected instruments also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 215-253-5020. We regret any inconvenience this action may cause you and if you have any questions, please contact Stryker Orthobiologics at 610-640-1775 x 5299.
Quantity in Commerce 9805
Distribution Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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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