FDAClass IIApril 26, 2017

Peri-loc(r) VLP 3.5 MM X 6 MM Self-tapping Cortex Screw recall: Labeling Error

Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic

Why was Peri-loc(r) VLP 3.5 MM X 6 MM Self-tapping Cortex Screw 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 15HM05197

Product
Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
Recalling firm
Smith & Nephew, Inc.
Quantity
1 unit
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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