FDAFDA · Food and drugs·Recall number Z-1066-2013
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
Published April 17, 2013 · Recall initiated: January 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Stelkast Co
- Distributor
- Nationwide Distribution including the states of NV, OK and PA.
- Lot
- Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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