Recall Z-2810-2015 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Stryker Howmedica Osteonics Corp.
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
| Date | Sep 23, 2015 (initiated Jun 25, 2015) |
| Status | Terminated |
| Reason | it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker Orthopaedics notified their branches via email on 6/25/2015. Notification letters and Product Accountability Forms were mailed to Stryker Branches/Agencies on 817/2015 and hospital risk management on 8/18/2015. |
| Quantity | 16 units |
| Distribution | Distributed in WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033716 | TRIDENT ACETABULAR SYSTEM Howmedica Osteonics Corp., Feb 10, 2005 |