Recall Z-2796-2015 ยท HRS Plate, Fixation, Bone
OrthoPediatrics Corp
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
| Date | Sep 18, 2015 (initiated Jul 28, 2015) |
| Status | Terminated |
| Reason | The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly. |
| Root cause | Packaging process control |
| Action | OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015. |
| Quantity | 5 |
| Distribution | Domestic: TN, IA Foreign: England VA/DOD: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM OrthoPediatrics Corp., Jun 17, 2011 |