Recall Z-0557-2010 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads.
| Date | Dec 22, 2009 (initiated Jan 14, 2009) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument. |
| Root cause | Device Design |
| Action | Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon. |
| Quantity | 786 total stems |
| Distribution | Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020615 | SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS Howmedica Osteonics Corp., May 13, 2002 |