FDA Recall
Terminated
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
Recall: Z-2780-2017
·
Initiated April 19, 2017
Recall
- Recall Number
- Z-2780-2017
- Event Number
- 77490
- Firm
- Ortho Solutions Inc
- FEI Number
- 3022270316
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- April 19, 2017
- Terminated
- March 19, 2019
- Address
- 330 Franklin Tpke, Mahwah, NJ, 07430-3524
Description
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
Reason
There is a material mislabeling of the AFN End Cap.
Action
Orthosol notified their customers on 4/19/2017 via USPS.
Distribution
US distribution to MD, NY & PA
Quantity
277 units