Ortho OS Solutions UltOS 3 recalled over sterility concerns

Recall date

July 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ortho Solutions Inc recalls Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spita…

Recall number

Z-0026-2016

FDA classification

Class II

Brand / firm

Ortho Solutions Inc

Sold / distributed

US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.

Why it was recalled

Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw