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Recall Observatory FDA recall evidence

Device 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.

Z-2297-2016

July 06, 2016

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 74617
Status
Terminated
Classification
Class II
Quantity
185 units
Official record key
device-enforcement:Z-2297-2016

Official wording

Reason: The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.

Code information: Lot Number 16AM14274

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.