Z-0276-2014 Class II Terminated
FDA device recall Z-0276-2014 was initiated by OrthoPediatrics Corp on September 26, 2013 and is designated Class II. Reason for recall: 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. Up… The recall status is terminated (terminated December 26, 2013). Affected quantity: 7 units shipped.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2013
- Initiation Date
- September 26, 2013
- Termination Date
- December 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units shipped
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
Code Information
Part Number:. 00-0903-2634 and lot number 009U2