Recall Z-2835-2016— Ortho Solutions Inc

Name: FDA recall Z-2835-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-21

Class II · Terminated

Class II FDA medical device recall by Ortho Solutions Inc, initiated 2016-07-21, terminated 2016-10-12. It names one FDA 510(k) clearance: K111678. Product: FPS 35mm x 3.5 mm non-locking screw. Reason: Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws..

Recalling firm: Ortho Solutions Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-21
Terminated: 2016-10-12
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K111678 — ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISOrtho Solutions Limited·cleared 2012-02-07

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

FPS 35mm x 3.5 mm non-locking screw

Reason for recall

Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

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