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.
FDA Recall Z-2780-2017 · Posted None
Recalling FirmOrtho Solutions Inc
Recall StatusTerminated
Product CodeHSB
Date Initiated2017-04-19
Date Terminated2019-03-19
Product Quantity277 units
Reason for Recall
There is a material mislabeling of the AFN End Cap.
Firm Action
Orthosol notified their customers on 4/19/2017 via USPS.
Root Cause
Error in labeling
Distribution Pattern
US distribution to MD, NY & PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.