Recall Z-0967-2018 ยท HWC Screw, Fixation, Bone
ORTHO SOLUTIONS, LTD.
SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS; OS900059-NS; OS900057-NS.
| Date | Oct 10, 2017 |
| Status | Terminated |
| Reason | Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market. |
| Root cause | Process control |
| Action | Ortho Solutions notified customers of the recall via letter 10/10/2017. The recall notification letter was accompanied by instructions to Distributors and a Product Removal Form. |
| Quantity | 120 |
| Distribution | U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163489 | OrthoSolutions 'System26' Bone Screws Ortho Solutions UK Limited, Mar 8, 2017 |