FDAClass IIJune 19, 2013

90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 recall

90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for…

Why was 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 recalled?

Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

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?

All lot numbers are affected. Catalog No. 00-1200-1000

Product
90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for…
Recalling firm
OrthoPediatrics Corp
Quantity
130 devices were shipped
Distribution
USA Nationwide Distribution
Recall date
June 19, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls