3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plati...

FDA Device Recall #Z-0276-2014 — Class II — September 26, 2013

Recall Summary

Recall Number Z-0276-2014
Classification Class II — Moderate risk
Date Initiated September 26, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm OrthoPediatrics Corp
Location Warsaw, IN
Product Type Devices
Quantity 7 units shipped

Product Description

3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.

Reason for Recall

The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.

Distribution Pattern

Worldwide Distribution - US including Michigan and the countries of Ireland and Australia

Lot / Code Information

Part Number:. 00-0903-2634 and lot number 009U2

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.