FDAClass IIApril 26, 2017

D-rad, 1.8mm X 16mm, Locking Peg, QTY recall: Labeling Error

D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic

Why was D-rad, 1.8mm X 16mm, Locking Peg, QTY recalled?

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

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?

Batch number 15KM05493

Product
D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Recalling firm
Smith & Nephew, Inc.
Quantity
19 units
Distribution
Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore
Recall date
April 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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