Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 pro...

FDA Device Recall #Z-2690-2014 — Class II — August 27, 2014

Recall Summary

Recall Number Z-2690-2014
Classification Class II — Moderate risk
Date Initiated August 27, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Justright Surgical, LLC
Location Boulder, CO
Product Type Devices
Quantity 3 cases containing 18 units

Product Description

Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.

Reason for Recall

JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut.

Distribution Pattern

Distributed in the states of Colorado, California and New York.

Lot / Code Information

Lot: 75DD0406

Other Recalls from Justright Surgical, LLC

Recall # Classification Product Date
Z-1956-2015 Class II JustRight 5mm Reload, JR-REL25-2.0 Reload is pa... Jun 11, 2015
Z-1955-2015 Class II JustRight 5mm Stapler, JR-ST25-2.0 Stapler is p... Jun 11, 2015
Z-2691-2014 Class II Justright Surgical, JustRight 5mm Reload, REFJR... Aug 27, 2014

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.