GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE ...
FDA Device Recall #Z-0448-2014 — Class II — August 27, 2013
Recall Summary
| Recall Number | Z-0448-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 27, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smith & Nephew Inc |
| Location | Memphis, TN |
| Product Type | Devices |
| Quantity | 46 pieces |
Product Description
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Reason for Recall
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
Distribution Pattern
Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.
Lot / Code Information
Batch No. 12GT20775
Other Recalls from Smith & Nephew Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0282-2025 | Class II | smith&nephew LEGION OXINIUM POSTERIOR STABILIZE... | Oct 2, 2024 |
| Z-0281-2025 | Class II | smith&nephew GENESIS II NONPOROUS POSTERIOR STA... | Oct 2, 2024 |
| Z-0277-2025 | Class II | smith&nephew LEIGON OXINIUM CONSTRAINED NONPORO... | Oct 2, 2024 |
| Z-0278-2025 | Class II | smith&nephew LEIGON OXINIUM CONSTRAINED NONPORO... | Oct 2, 2024 |
| Z-1901-2024 | Class II | smith&nephew OXINIUM Femoral Head 12/14 Taper, ... | Apr 24, 2024 |
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.