FDA-Device2015-10-14Class II
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
Ortho Solutions Inc
Hazard
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
Sold states
US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.
Affected count
875 units
Manufactured in
330 Franklin Tnpk, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0026-2016Don't want to check this manually?
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