Manufacturer
34 recalls in our database name Conformis, Inc. as the manufacturing or recalling firm.
Of the 34 recalls from Conformis, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
ConforMIS, Inc. is recalling 313 units of the iTotal CR Knee Replacement System due to potential small amounts of ethylene glycol residue.
ConforMIS, Inc. is recalling 71 units of the ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial due to potential small amounts of ethylene glycol residue.
ConforMIS is recalling 110 units of the iTotal Posterior Stabilized Knee Replacement System because they may contain small amounts of ethylene glycol residue.
ConforMIS, Inc. is recalling 348 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.
ConForMIS is recalling 6 units of the iUNI Unicondylar Knee Replacement System due to potential ethylene glycol residue.
ConforMIS, Inc. is recalling 3 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.
ConforMIS, Inc. is recalling 12 units of the iDuo Knee Bicompartmental Knee Replacement System because they may contain small amounts of ethylene glycol residue.
ConforMIS, Inc. is recalling one unit of the iTotal CR G2 Knee Replacement System due to an incorrect serial number on the tibial insert packaging.
Conformis Inc is recalling 1,427 iTotal CR Knee Replacement Systems to add a labeling addendum with detailed surgical instructions for poly insertion.