Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla ...
FDA Device Recall #Z-2056-2013 — Class II — July 17, 2013
Recall Summary
| Recall Number | Z-2056-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 17, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Integra Limited |
| Location | Plainsboro, NJ |
| Product Type | Devices |
| Quantity | 65 |
Product Description
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
Reason for Recall
As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.
Distribution Pattern
Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.
Lot / Code Information
Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
Other Recalls from Integra Limited
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1338-2019 | Class II | Integra Flowable Wound Matrix Catalog No: FWD3... | Mar 31, 2019 |
| Z-1089-2019 | Class II | Integra bioBLOCK Resorbable subtaler Implant, 1... | Mar 1, 2019 |
| Z-1091-2019 | Class II | Integra bioBLOCK Resorbable subtaler Implant, 1... | Mar 1, 2019 |
| Z-1090-2019 | Class II | Integra bioBLOCK Resorbable subtaler Implant, 1... | Mar 1, 2019 |
| Z-0117-2014 | Class II | Brand Names: Integra¿ Camino 110-4 Intracranial... | Sep 10, 2013 |
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.