FDAClass IIAugust 3, 2016

Spherical Head recall

SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for…

Why was Spherical Head recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 16AM14274

Product
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for…
Recalling firm
Smith & Nephew, Inc.
Quantity
185 units
Distribution
Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR
Recall date
August 3, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls