Recall Z-0276-2014 ยท HRS Plate, Fixation, Bone
OrthoPediatrics Corp
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a g
| Date | Nov 14, 2013 (initiated Sep 26, 2013) |
| Status | Terminated |
| Reason | The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics. |
| Root cause | Labeling mix-ups |
| Action | OrthoPediatrics sent an Urgent Medical Device Recall letter dated September 26, 2013, to all affected customers.The letter identified the product the problem and the actions needed to be taken by the customer The sales representatives and distributors who have been identified via shipping records as having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on 18-September-2013. If you or any of your customers have any of these devices in the original packaging please take possession of them and quara |
| Quantity | 7 units shipped |
| Distribution | Worldwide Distribution - US including Michigan and the countries of Ireland and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.