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.
Enforcement
- Recall Number
- Z-0276-2014
- Event ID
- 66450
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- OrthoPediatrics Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 20, 2013
- Initiation Date
- September 26, 2013
- Classification Date
- November 14, 2013
- Termination Date
- December 26, 2013
- Address
- 2850 Frontier Dr, Warsaw, IN, 46582-7001, United States
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.
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.
Part Number:. 00-0903-2634 and lot number 009U2
Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
7 units shipped