Recall Z-0286-2013 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection.
| Date | Nov 13, 2012 (initiated Jul 16, 2012) |
| Status | Terminated |
| Reason | Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem. |
| Root cause | Device Design |
| Action | Stryker Orthopaedics sent an Urgent Product Recall letter dated July 16, 2012 via Fed Ex with return receipt to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers to contact their Stryker Sales Representative to arrange for return of the affected product. Customers were instructed to fax back the attached Product Recall Acknowledgement Form to 201-821-6069. For questions call 201-972-2100. |
| Quantity | 301 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.