Every recall we track for Conformis Inc. — 18 in all — plus the complaints and injury reports the public filed about them.
Conformis recalls specific acetabular liner models for hip systems due to incorrect labeling. This may lead to improper use. Affected customers should contact Conformis for details.
Conformis recalls Identity Imprint PS Tibial Tray Size : Lot 540287 due to packaging mix-up between lots 540287 and 508287. This may lead to incorrect product use.
Conform: Hip screws labeled 25mm but actually 30mm may cause improper fit. Affected units: Model HAA-030-0625-000101, Lot 1232071. Contact manufacturer for details.
Conformis recalls iTotal Identity Impactor Handle Model 1080-212/ED-07827 REV AE due to risk of screw falling into patient during procedures. Affected units have specific model and lot numbers.
Conformis recalls iTotal Identity Posterior Stabilised Knee Replacement System model TPS-301-1113-020101 due to incorrect tibial base plate implant packaging. Affected units have specific serial numbers and UDI codes.
Conformis recalls iTotal Hip Replacement System model HAA-050-D02: Incorrect hip components in kits may lead to improper joint replacement. Affected units have serial numbers 0469255.
Conformis recalls iTotal CR knee implants with incorrect box contents. Check serial number 0469247 (exp 2021-01-31) for affected units. No immediate action needed.
Conformis recalls a limited number of iTotal CR Knee Replacement System implants due to incorrect serial number labeling causing delivery to the wrong customer accounts. Affected units may need verification.
Conformis recalls a limited number of iTotal PS knee replacement systems with incorrect serial numbers delivered to the wrong customers. This does not pose a safety risk but requires correction of labeling.
Conformis recalls iTotal CR Knee Replacement System model TCR-111-1111-010102 due to medial and lateral polyethylene inserts not securely fitting into the cobalt chrome tray implant.
Conformis recalls iTotal Hip Replacement System Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right due to two femoral stems being switched in packaging. Affected patients should contact the manufacturer for details.
Conformis recalls hip replacement stems Model HBS-033-0015-020101 Size 15 due to switched packaging. Patients may receive incorrect stem size.
Conformis recalls specific hip replacement implants due to 3mm discrepancy between iViews measurements and actual implant neck/head lengths, potentially causing improper fit.
Conformis recalls specific hip replacement stems due to 3mm discrepancy between iViews measurements and actual implant neck/head lengths, potentially causing improper fit.
Conformis recalls iTotal Posterior Stabilized knee replacement systems with mismatched labeling on boxes and pouches. Affected units include specific catalog and serial numbers. Consumers should contact Conformis for details.
Conformis recalls iTotal CR Total Knee Replacement Systems with incorrect patient ID labels and components. This could lead to wrong patient matches during surgery. Affected units have specific model numbers and serial numbers.
Conformis recalls hip replacement system with stage 1/2 reamer instruments that may cause bone damage due to improper fit. Affected units have specific catalog and serial numbers.
