Z-2780-2017 Class II Terminated

Recalled by Ortho Solutions Inc — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
August 9, 2017
Initiation Date
April 19, 2017
Termination Date
March 19, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
277 units

Product 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 for Recall

There is a material mislabeling of the AFN End Cap.

Distribution Pattern

US distribution to MD, NY & PA

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