3.5mm Locking Screw recall: Labeling Error
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one…
Why was 3.5mm Locking Screw recalled?
The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
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:. 00-0903-2634 and lot number 009U2
- Product
- 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one…
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 7 units shipped
- Distribution
- Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
- Recall date
- November 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)