Smith & Nephew, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2297-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 6, 2016

Date Posted: August 3, 2016

Recall Number: Z-2297-2016

Event ID: 74617

Reason for Recall:

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

Status: Terminated

Product Quantity: 185 units

Code Information:

Lot Number 16AM14274

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated