Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is inten...

FDA Device Recall #Z-2742-2020 — Class II — July 6, 2020

Recall Summary

Recall Number Z-2742-2020
Classification Class II — Moderate risk
Date Initiated July 6, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm OrthoPediatrics Corp
Location Warsaw, IN
Product Type Devices
Quantity 73 units

Product Description

Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053

Reason for Recall

Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device

Distribution Pattern

US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.

Lot / Code Information

Lot Number: 108332-A UDI: (01)0084113212400(10)108332A

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-2539-2020 Class II OrthoPediatrics ACL Reconstruction System Shiel... Jun 5, 2020
Z-2538-2020 Class II OrthoPediatrics ACL Reconstruction System Shiel... Jun 5, 2020
Z-0218-2020 Class II Model No. 01-1501-0032 (Child Nail Attachment B... Aug 19, 2019

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.