Recall Z-1384-2013— Orthopedic Alliance LLC
Class II · Terminated
Class II FDA medical device recall by Orthopedic Alliance LLC, initiated 2013-02-20, terminated 2014-03-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Orthopedic Alliance LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-20
- Terminated
- 2014-03-26
- Firm location
- Murrieta, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.