Recall Z-0891-2009 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Omnifit HA Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
| Date | Jan 26, 2009 (initiated Nov 13, 2008) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. |
| Root cause | Packaging |
| Action | Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718. |
| Quantity | 322 total units - all types |
| Distribution | Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982032 | OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS Osteonics Corp., Jul 9, 1998 |