FDAFDA · Food and drugs·Recall number Z-1066-2014
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
Published March 5, 2014 · Recall initiated: January 23, 2014
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
Inner spherical radius of the shell is undersized.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smith & Nephew Inc
- Distributor
- Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
- Lot
- Batch No. 13EM03053
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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