Recall Z-1703-2009 ยท MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Stryker Howmedica Osteonics Corp.
Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.
| Date | Aug 4, 2009 (initiated Jun 9, 2009) |
| Status | Terminated |
| Reason | The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique. |
| Root cause | Labeling design |
| Action | Stryker sent Urgent - Product Correction - Surgical Protocol letters by Federal Express on June 9, 2009 to all Stryker branches/agencies, hospital Risk Management, hospital Chief of Orthopaedics, surgeons and all foreign consignees. |
| Quantity | 2376 in USA, 1326 internationally |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.