Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Numbe...
FDA Device Recall #Z-1509-2022 — Class II — July 22, 2022
Recall Summary
| Recall Number | Z-1509-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 22, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Corin Ltd |
| Location | Cirencester |
| Product Type | Devices |
| Quantity | 5 devices |
Product Description
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Reason for Recall
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
Distribution Pattern
US Nationwide distribution in the states of OK, TX, FL.
Lot / Code Information
UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630
Other Recalls from Corin Ltd
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0214-2024 | Class II | Unity Total Knee System, Model Number 112.001.3... | Oct 13, 2023 |
| Z-0213-2024 | Class II | Unity CR Femur Right, Size 6, Model Number 112.... | Oct 13, 2023 |
| Z-0726-2023 | Class II | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm... | Nov 8, 2022 |
| Z-0727-2023 | Class II | Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm... | Nov 8, 2022 |
| Z-0273-2023 | Class II | Unity Total Knee System. Used for knee pro... | Oct 31, 2022 |
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.