Recall Z-1536-2013 ยท HWC Screw, Fixation, Bone
OrthoPediatrics Corp
90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, i
| Date | Jun 12, 2013 (initiated Apr 19, 2013) |
| Status | Terminated |
| Reason | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively. |
| Root cause | Device Design |
| Action | OrthoPediatrics sent an Urgent Voluntary Recall notifiation via telephone and email to all affected consignees. The letter instructed consignees to take possession of any affected devices and quarantine immediately. A Mandatory Reply Form is included with the notification letter to be completed and returned. Please contact Greg Teghtmeyer if you have any questions (574-268-6379). |
| Quantity | 130 devices were shipped |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110959 | ORTHOPEDIATRICS BLADE PLATE SYSTEM OrthoPediatrics Corp., Aug 5, 2011 |