FDAFDA · Food and drugs·Recall number Z-0276-2014
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
Published November 20, 2013 · Recall initiated: September 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
- Lot
- Part Number:. 00-0903-2634 and lot number 009U2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.