Recall Z-1915-2009 ยท IQO Device, Prosthesis Alignment
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.
| Date | Aug 26, 2009 (initiated Sep 11, 2007) |
| Status | Terminated |
| Reason | The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking |
| Root cause | Device Design |
| Action | Stryker Orthopaedics issued an "Important Product Removal" letter dated September 11, 2007 via Federal Express informing consignees of the affected devices. The firm requested that users identify and return any affected product and account for product by returning a Product Accountability Form via fax. For further information, contact Stryker Orthopaedics at 1-201-831-5825. |
| Quantity | 615 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.