Recall Z-0026-2016 ยท HWC Screw, Fixation, Bone
Ortho Solutions Inc
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
| Date | Oct 6, 2015 (initiated Jul 14, 2015) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Ortho Solutions Group, sent an "Urgent Medical Device Recall" notifications and "Effectiveness or Recall Declaration Forms" dated 14 July 2015. The notification informed the consignee of the issue, clinical risks, how to identify the affected product, and the actions the consignees were requested to take. Requested actions included reviewing product on-hand, ceasing distribution of affected product and arrangement for product to be returned to Ortho Solutions, Inc. within 2 working days. Consignees were also requested to fill out the Recall Declaration Form and return it to Ortho |
| Quantity | 875 units |
| Distribution | US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141784 | ORTHO SOLUTIONS ULTOS PLATING SYSTEM Ortho Solutions Limited, Jul 23, 2014 |