Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Pro...
FDA Device Recall #Z-2145-2012 — Class II — July 14, 2012
Recall Summary
| Recall Number | Z-2145-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 14, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smith & Nephew, Inc. Endoscopy Division |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 108 units |
Product Description
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.
Reason for Recall
Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.
Lot / Code Information
Lot Numbers: 655844R, 950143R, 950144R, 950145R, 950146R
Other Recalls from Smith & Nephew, Inc. Endoscopy Division
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2045-2014 | Class II | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabr... | Jun 2, 2014 |
| Z-2049-2014 | Class II | SUTUREFIX Ultra S Double Loaded Suture Product... | Jun 2, 2014 |
| Z-2046-2014 | Class II | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabr... | Jun 2, 2014 |
| Z-2047-2014 | Class II | SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) ... | Jun 2, 2014 |
| Z-2048-2014 | Class II | SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (... | Jun 2, 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.