FDA recall Z-2780-2017

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.

Reason for recall

There is a material mislabeling of the AFN End Cap.

Distribution

US distribution to MD, NY & PA

Key facts

Status

Terminated

Initiation date

2017-04-19

Report date

2017-08-09

Termination date

2019-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2780-2017