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

Reason: 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

Code information: Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)

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