Recall Z-0934-2014 ยท HWC Screw, Fixation, Bone
OrthoPediatrics Corp
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
| Date | Feb 6, 2014 (initiated Jan 8, 2014) |
| Status | Terminated |
| Reason | OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524. |
| Root cause | Labeling mix-ups |
| Action | Orthopediatrics Corporation has requested sales representatives and distributors who have been identified via shipping records as having the possibility of having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on January 8, 2014. The decision to Recall these devices was made and a formal written Recall Notice sent to the consignees via email on January 13, 2014. Notification will not be sent to hospitals at this time provided that all devices are retrieved or accounted for within 60 days of the ini |
| Quantity | 12 units |
| Distribution | Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.