FDAFDA · Food and drugs·Recall number Z-0408-2014
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Published December 4, 2013 · Recall initiated: July 31, 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
There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- USA Nationwide Distribution
- Lot
- Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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