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Smith & Nephew Inc recalls Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use
Recalled March 5, 2014 · FDA recall Z-1066-2014 · Smith & Nephew
Hazard
Inner spherical radius of the shell is undersized. · FDA Class II
Units
10 units
Sold at
Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
Description
Inner spherical radius of the shell is undersized.
Product
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.
Manufacturer(s)
Smith & Nephew Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →