Ortho Solutions Inc Recalls
Showing 1-2 of 2 recalls
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
There is a material mislabeling of the AFN End Cap.
Orthosol notified their customers on 4/19/2017 via USPS.
FPS 35mm x 3.5 mm non-locking screw
Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
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 sign and return the "Field Safety Corrective Action Declaration Form", by which to confirm they have received the "Field Safety Notice" and that they declare that the required recall has been completed at their hospital. For further questions, call (201) 258-7305.