Recall Z-2780-2017— Ortho Solutions Inc

Name: FDA recall Z-2780-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-19

Class II · Terminated

Class II FDA medical device recall by Ortho Solutions Inc, initiated 2017-04-19, terminated 2019-03-19. It names one FDA 510(k) clearance: K121575. 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: There is a material mislabeling of the AFN End Cap..

Recalling firm: Ortho Solutions Inc
Classification: Class II
Status: Terminated
Initiated: 2017-04-19
Terminated: 2019-03-19
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K121575 — OXFORD ANKLE FUSION NAIL(AFN) SYSTEMOrtho Solutions Limited·cleared 2012-09-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.