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SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF… recallZ-2297-2016 · Smith & Nephew, Inc. · initiated Jul 6, 2016

Class II Terminated All recalls posted in July 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

Smith & Nephew sent an Urgent Product Recall Notification letter dated July 6, 2016, to all affected consignees via email and FedEx Overnight delivery on July 6, 2016. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were asked to inspect their inventory and located any unused affected devices and quarantine them immediately, complete the Inventory Return Certification Form and fax to 1-901-566-7975 indicating the quantities that need to be returned. Consignees should contact Smith & Nephew's Field Actions Department via email at [email protected] to obtain a return authorization (RA) number. For questions regarding this recall call 901-399-5520.

Recall details

Recall number
Z-2297-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 6, 2016
Posted by the FDA
Jul 28, 2016
Recalling firm
Smith & Nephew, Inc.
Quantity
185 units
Product code
MEH
FDA submissions
K990666
Distribution
Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR

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.

Code information (models, lots, serial numbers)

Lot Number 16AM14274

Other devices under the same FDA submission

13 devices cleared under K990666 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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