FDA-Device2014-03-05Class II
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.
Smith & Nephew Inc
Hazard
Inner spherical radius of the shell is undersized.
Sold states
Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.
Affected count
10 units
Manufactured in
1450 E. Brooks Rd, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1066-2014Don't want to check this manually?
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