ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020...
FDA Device Recall #Z-0146-2016 — Class II — August 31, 2015
Recall Summary
| Recall Number | Z-0146-2016 |
| 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 | 348 units |
Product Description
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
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): 0353281 0355761 0352418 0353880 0354092 0354675 0354821 0355543 0354327 0352462 0354838 0352276 0355506 0355440 0353788 0354652 0349894 0350379 0352905 0354025 0355196 0355405 0355622 0351034 0353474 0353739 0354763 0354158 0355067 0354429 0354764 0353422 0354285 0355646 0355282 0354831 0353993 0355861 0354799 0355519 0353322 0355546 0355319 0355287 0353365 0353987 0355191 0356013 0352467 0354363 0350372 0354462 0355162 0355296 0355070 0354734 0352448 0354116 0353782 0353342 0353040 0355522 0354034 0354476 0354835 0353424 0351578 0353329 0353597 0354408 0354814 0352783 0352940 0352894 0353027 0353492 0352780 0353125 0353929 0353457 0354128 0352830 0354543 0353393 0350374 0353510 0353659 0354329 0354731 0352356 0353996 0353719 0353536 0354611 0353718 0353698 0355577 0355086 0354261 0355369 0352721 0354791 0353907 0354348 0354083 0354913 0353906 0353137 0354217 0355388 0354078 0351433 0353445 0353568 0353678 0355184 0355410 0354357 0354489 0349625 0353344 0354380 0355092 0355190 0355487 0353694 0352789 0355276 0350717 0351645 0351801 0351974 0353200 0353731 0353746 0352301 0353879 0355686 0353555 0352497 0351892 0352645 0353953 0354234 0353091 0353676 0353892 0353525 0353686 0354689 0352675 0352730 0354700 0349501 0354997 0355558 0348201 0354797 0352094 0351889 0353314 0353651 0352070 0353667 0354331 0354949 0354367 0354123 0353835 0354317 0353893 0354935 0353266 0355161 0354833 0353760 0353282 0349733 0352323 0354580 0354704 0349884 0352561 0354060 0353925 0352785 0353414 0354027 0355221 0355347 0355571 0354042 0351810 0351812 0352036 0353837 0353984 0352303 0352740 0354480 0354053 0354093 0356023 0353593 0355366 0354574 0355256 0355218 0353693 0354564 0352800 0353325 0349995 0355358 0353830 0353016 0354368 0354750 0353876 0354153 0353637 0354583 0351816 0350919 0343328 0354482 0355106 0353594 0354469 0355281 0352949 0354302 0355040 0353754 0354253 0355183 0353844 0350226 0350235 0350640 0354839 0353797 0352982 Serial Numbers: OUS 0352548 0350661 0354384 0352569 0354309 0354526 0351329 0354547 0353319 0353211 0355378 0354852 0355036 0354238 0355207 0354568 0353641 0352588 0352589 0355198 0355329 0355402 0355652 0355210 0354009 0354235 0353199 0355666 0355098 0355060 0354320 0354626 0354639 0355052 0354569 0354326 0354655 0352087 0352203 0354562 0355073 0355466 0351749 0353709 0354067 0354070 0352876 0353145 0353521 0353246 0353350 0349077 0349954 0351376 0354011 0354290 0353216 0353710 0352862 0353295 0352778 0353992 0352839 0352716 0353658 0353578 0352407 0353213 0354444 0354386 0353800 0353240 0353291 0354199 0355061 0354623 0355051 0354919 0354068 0353253 0354607 0354187 0354535 0354787 0351890 0353874 0354657 0353776 0352601 0354688 0353982 0354177 0352469 0352470 0354458 0352859 0354824 0354733 0355094 0355211 0349709 0354933 0352084 0354403 0353184
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.