Recall Z-2835-2016 ยท HWC Screw, Fixation, Bone
Ortho Solutions Inc
FPS 35mm x 3.5 mm non-locking screw
| Date | Jul 21, 2016 |
| Status | Terminated |
| Reason | Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. |
| Root cause | Labeling mix-ups |
| Action | Ortho Solutions sent a "Field Safety Notice" letter dated July 21, 2016 to their affected customers. The letter identify the Solutions Business Development Manager will contact the customer to arrange for the isolation and removal of the unused product from their inventory. Replacement product will be provided. The customer was advised to passed on the "Field Safety Notice" to all who need to be aware within their organization and to any organization to which their have further distributed or transferred the affected screw. Upon removal of the affected device, customers are asked to please si |
| Quantity | 15 |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111678 | ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS Ortho Solutions Limited, Feb 7, 2012 |