Recall Z-1198-2012 ยท KIH Dispenser, Cement
Stryker Instruments Div. of Stryker Corporation
Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.
| Date | Mar 12, 2012 (initiated Jan 13, 2012) |
| Status | Terminated |
| Reason | The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proximal Pressurizer P/N 0206-556-000 while the product inside the package was Femoral Pressurizer P/N 0206-566-000. |
| Root cause | Mixed-up of materials/components |
| Action | Stryker Instruments sent an "Urgent Medical Device Recall notification" dated January 13, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : Immediately check all stock areas or operating room storage and quarantine any affected product found. Mark product as RECALLED PRODUCT. Please indicate on the BRF the quantity of affected Pressurizers you are returning and fill in the form completely. Sign the BRF (even if you do not have any affected product). Note: Your signature on |
| Quantity | 10 boxes (60 units) |
| Distribution | Worldwide Distribution -- Nationwide, including the states of AL and OK and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.