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Smith & Nephew, Inc. recalls SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip compone
Recalled August 3, 2016 · FDA recall Z-2297-2016 · Smith & Nephew
Hazard
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw. · FDA Class II
Units
185 units
Sold at
Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR
Description
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Product
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →