Z-1384-2013 Class II Terminated
FDA device recall Z-1384-2013 was initiated by Orthopedic Alliance LLC on February 20, 2013 and is designated Class II. Reason for recall: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to… The recall status is terminated (terminated March 26, 2014). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2013
- Initiation Date
- February 20, 2013
- Termination Date
- March 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
Reason for Recall
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Distribution Pattern
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Code Information
Item No. 5201-6715 5201-6720 5201-6725 5201-6730 5201-6735 5201-6740