iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LE...
FDA Device Recall #Z-1628-2020 — Class II — February 3, 2020
Recall Summary
| Recall Number | Z-1628-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 3, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Conformis, Inc. |
| Location | Billerica, MA |
| Product Type | Devices |
| Quantity | 2 |
Product Description
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
Reason for Recall
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Distribution Pattern
US Nationwide distribution in the states of LA, NY, TN.
Lot / Code Information
0460018 0460118
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.