Recall Z-1621-2024 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
| Date | Apr 25, 2024 (initiated Feb 27, 2024) |
| Status | Open, Classified |
| Reason | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to |
| Quantity | 0 |
| Distribution | Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171768 | Trident® II Acetabular System Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, Oct 2, 2017 |