Recalls / —
—#75482
Product
Omnifit Eon 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.
- FDA product code
- JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K983226
- Affected lot / code info
- 6098-0630 OMNIFIT EON 132 48HMME, 6098-0630 OMNIFIT EON 132 TAMMME, 6098-0735 OMNIFIT EON 132 0W9MNE, 6098-0940 OMNIFIT EON 132 TN3MLE and 6098-1140 OMNIFIT EON 132 2HNMME
Why it was recalled
Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
Root cause (FDA determination)
Packaging
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
Timeline
- Recall initiated
- 2008-11-13
- Posted by FDA
- 2009-01-26
- Terminated
- 2010-01-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #75482. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.