Recall Z-2772-2015
Orthovita, Inc., dBA Stryker Orthobiologics. · initiated August 20, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505
Reason for recall
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2772-2015
- Initiated
- August 20, 2015
- Posted by FDA
- September 16, 2015
- Terminated
- March 10, 2017
- Product code
- KIH – Dispenser, Cement
- Quantity
- 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.
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics., Malvern, PA