Recall Z-1534-2013
OrthoPediatrics Corp · initiated April 19, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
90 Degree Cannulated Infant Blade Plate 25mm 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.
Codes / lots: All lot numbers are affected. Catalog No. 00-1200-1000
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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).
Details
- Recall number
- Z-1534-2013
- Initiated
- April 19, 2013
- Posted by FDA
- June 12, 2013
- Terminated
- September 19, 2013
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 130 devices were shipped
- Distribution
- USA Nationwide Distribution
- Recalling firm
- OrthoPediatrics Corp, Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1535-2013 Class II | 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The…Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five… | 04/19/2013Terminated |
| Z-1536-2013 Class II | 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The…Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five… | 04/19/2013Terminated |