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, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Recall
- Recall Number
- Z-1536-2013
- Event Number
- 65091
- Firm
- OrthoPediatrics Corp
- FEI Number
- 3006460162
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 19, 2013
- Posted
- June 12, 2013
- Terminated
- September 19, 2013
- Address
- 2850 Frontier Dr, Warsaw, IN, 46582-7001
Description
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, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
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.
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).
USA Nationwide Distribution
130 devices were shipped