OrthoPediatrics PediNail Intramedullary Nailing System recall
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Why was OrthoPediatrics PediNail Intramedullary Nailing System recalled?
Labeled as a 48mm Cortical Screw but measuring at 50mm
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?
Product Number: 10-1500-3048 Lot Number: 161421-G
- Product
- OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 22 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.
- Recall date
- December 28, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)