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Recall Observatory FDA recall evidence

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

April 19, 2017

Class II

Product summary

Firm
Ortho Solutions Inc
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

    reason.labeling_packaging · v1.0.0

    mislabeling