ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ...
FDA Device Recall #Z-0144-2016 — Class II — August 31, 2015
Recall Summary
| Recall Number | Z-0144-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 31, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ConforMIS, Inc. |
| Location | Bedford, MA |
| Product Type | Devices |
| Quantity | 3 units |
Product Description
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
Reason for Recall
May contain small amounts of ethylene glycol residue
Distribution Pattern
Distributed Nationwide and in Germany, Switzerland, and UK.
Lot / Code Information
Serial Numbers (US): 0354697, 0353789, 0354533
Other Recalls from ConforMIS, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1591-2024 | Class II | Identity Imprint PS Tibial Tray Size 4: Lot 540287 | Mar 11, 2024 |
| Z-2405-2023 | Class II | CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO | Jun 16, 2023 |
| Z-1133-2023 | Class II | iTotal Identity Impactor Handle, Model No. 1080... | Nov 14, 2022 |
| Z-0899-2022 | Class II | iTotal Identity Posterior Stabilised (PS) Knee ... | Feb 22, 2022 |
| Z-0475-2021 | Class II | iTotal Hip Replacement System, Model number HAA... | Sep 21, 2020 |
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.