90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatr...
FDA Device Recall #Z-1536-2013 — Class II — April 19, 2013
Recall Summary
| Recall Number | Z-1536-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 19, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | OrthoPediatrics Corp |
| Location | Warsaw, IN |
| Product Type | Devices |
| 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
Lot / Code Information
All lot numbers are affected. Catalog No. 00-1200-1002
Other Recalls from OrthoPediatrics Corp
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0277-2023 | Class II | Orthex Large Bone Shoulder Bolt, model no. AS-17 | Sep 12, 2022 |
| Z-1678-2022 | Class II | Orthex External Fixation Wire Sharp Bayonet 1.... | Jun 29, 2022 |
| Z-2742-2020 | Class II | Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM ... | Jul 6, 2020 |
| Z-2538-2020 | Class II | OrthoPediatrics ACL Reconstruction System Shiel... | Jun 5, 2020 |
| Z-2539-2020 | Class II | OrthoPediatrics ACL Reconstruction System Shiel... | Jun 5, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.