Z-1536-2013 Class II Terminated
FDA device recall Z-1536-2013 was initiated by OrthoPediatrics Corp on Apr 19, 2013 and is designated Class II. 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. The recall status is terminated (terminated Sep 19, 2013). Affected quantity: 130 devices were shipped.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2013
- Initiation Date
- Apr 19, 2013
- Termination Date
- Sep 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 devices were shipped
Product 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.
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.
Distribution Pattern
USA Nationwide Distribution
Code Information
All lot numbers are affected. Catalog No. 00-1200-1002
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1536-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026