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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74617

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 06, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smith & Nephew, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2297-2016
Initiated
July 06, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
185 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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