FDAClass IIAugust 1, 2012

OrthoPediatrics PediLoc Locking Plate System recall

OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for…

Why was OrthoPediatrics PediLoc Locking Plate System recalled?

The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

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: 7736703 and part number: 00-1050-4308

Product
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for…
Recalling firm
OrthoPediatrics Corp
Quantity
15 devices
Distribution
Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Recall date
August 1, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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