FDA Device recall Z-1536-2013
90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is int…
- FDA Device
- Class II
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class II recall of 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is int… by Orthopediatrics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1536-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-19 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthopediatrics |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | All lot numbers are affected. Catalog No. 00-1200-1002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1536-2013%22
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