Device product
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.
Z-2780-2017
Product summary
- Event
- Event 77490
- Status
- Terminated
- Classification
- Class II
- Quantity
- 277 units
- Official record key
device-enforcement:Z-2780-2017
Official wording
Reason: There is a material mislabeling of the AFN End Cap.
Code information: Item Code OS331107 S1009023 Mar-2017 S1009023 Mar-2017 Item Code OS331104 S1009020 Apr-2017 Item Code OS331100 995035 Aug-2017; Jan-2018 Item Code OS331100 S1212114 May-2018 Item Code OS331101 S1009017 Jun-2018 Item Code OS331103 S1009019 Oct-2018 Item Code OS331105 S1102004 Oct-2018 Item Code OS331100 S1307176 Nov-2018, Dec-2018 S1401116 Apr-2019 Item Code OS331103 S1009019 May-2019 Item Code OS331105 S1102004 May-2019 Item Code OOS331100 7802 Oct-2019
Distribution pattern: US distribution to MD, NY & PA
Derived failure modes
-
Labeling or packaging
mislabeling