Recall Z-0086-2010 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Ortho Development Corporation
Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
| Date | Oct 28, 2009 (initiated Apr 29, 2009) |
| Status | Terminated |
| Reason | A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances. |
| Root cause | Device Design |
| Action | Ortho sent a Field notification Memo dated 4/2/2009 to agents and distributors, giving them pre-implant examination guidelines. Decision to recall non-implanted units was made on 4/29/2009 and this was communicated by telephone to distributors. |
| Quantity | 23 |
| Distribution | AZ, CA, FL, MA, MI. No military, government or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050966 | PIVOT BIPOLAR FEMORAL HEAD Ortho Development Corp., Jul 7, 2005 |