FDAClass IISeptember 30, 2015

3.5mm Non Locking Cortical Screw recall

3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in…

Why was 3.5mm Non Locking Cortical Screw recalled?

The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.

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?

Part number 00-0903-2510, Lot number 150192-J

Product
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in…
Recalling firm
OrthoPediatrics Corp
Quantity
5
Distribution
Domestic: TN, IA Foreign: England VA/DOD: None
Recall date
September 30, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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