Recall Z-2772-2015 ยท KIH Dispenser, Cement
Orthovita, Inc., dBA Stryker Orthobiologics.
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
| Date | Sep 16, 2015 (initiated Aug 20, 2015) |
| Status | Terminated |
| Reason | Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration |
| Root cause | 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 Acknowl |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.