Manufacturer

Conformis, Inc.

34 recalls in our database name Conformis, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 34
Critical: 0
Severe: 0
Most recent: 2025-04-23

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.

About this listing

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.

1–25 of 34

HighFDA (Devices)·Z-1569-2025·2025-04-23
Conformis Restor3d Cordera Hip Acetabular Liner Mislabeled
Conformis is recalling certain Cordera Hip acetabular liners from Lot 1788258 due to incorrect labeling. Units labeled as standard liners actually contain hooded liners, creating a mismatch between the label and the product.
Product
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2024·2024-04-24
Conformis Identity Imprint PS Tibial Tray Size 4 Packaging Error
Conformis is recalling Identity Imprint PS Tibial Tray Size 4 implants due to a packaging error where Size 5 components were placed in Size 4 boxes with incorrect lot numbers.
Product
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2405-2023·2023-08-23
Hip Screw Labeled as Wrong Size: 30mm Screws Mislabeled as 25mm
Conformis hip screws measuring 30mm have been mislabeled as 25mm, creating risk of incorrect surgical implantation. The recall affects 25 units distributed across nine states.
Product
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1133-2023·2023-02-22
iTotal Identity Impactor Handle surgical screws may loosen during procedures
Conformis Inc. is recalling the iTotal Identity Impactor Handle due to potential loose screws that could fall into patients during surgical procedures. Approximately 70 units from lot D221301 were distributed across multiple U.S. states.
Product
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2022·2022-04-20
iTotal Identity Knee Replacement System—incorrect tibial base plate packaged
Conformis is recalling specific units of the iTotal Identity Posterior Stabilised Knee Replacement System due to incorrect tibial base plate implants being packaged in surgical kits.
Product
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0475-2021·2020-12-02
Conformis Recalls iTotal Hip Replacement System Due to Incorrect Components
Conformis, Inc. is recalling two iTotal Hip Replacement Systems because incorrect hip components were provided in the kits.
Product
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2849-2020·2020-09-02
Conformis iTotal Knee Implant Kit Recalled for Incorrect Contents
Conformis, Inc. is recalling one iTotal CR Knee Replacement kit because the box contained implants and jigs for a different serial number.
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1627-2020·2020-04-08
Conformis Recalls iTotal CR Knee Replacement System Due to Labeling Error
Conformis, Inc. is recalling four iTotal CR Knee Replacement System kits because they were labeled with incorrect serial numbers and delivered to the wrong customers.
Product
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE 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 b
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1628-2020·2020-04-08
Conformis Recalls iTotal PS Knee Replacement System Due to Labeling Error
Conformis is recalling two iTotal PS Knee Replacement System kits because tibial trays were labeled with incorrect serial numbers and delivered to the wrong customers.
Product
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 sol
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0672-2020·2019-12-18
Conformis Recalls iTotal CR Knee Replacement System Due to Fit Issues
Conformis, Inc. is recalling the iTotal CR Knee Replacement System because the polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Product
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0064-2020·2019-10-16
Conformis Recalls iTotal Hip Replacement Stems Due to Packaging Error
Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems because sizes 13 and 15 were packed in each other's packaging.
Product
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0063-2020·2019-10-16
Conformis iTotal Hip Replacement Stems Recalled for Packaging Error
Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems (sizes 13 and 15) because they were packed in each other's packaging.
Product
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1775-2019·2019-06-19
Conformis iTotal Hip Replacement System Recalled for Dimensional Discrepancy
Conformis, Inc. is recalling 128 iTotal Hip Replacement System stems due to a 3mm discrepancy between approved and manufactured neck/head lengths.
Product
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1776-2019·2019-06-19
Conformis iTotal Hip Replacement System Recalled for Dimensional Discrepancy
Conformis is recalling 183 iTotal Hip Replacement System stems nationwide due to a 3mm discrepancy between approved and manufactured neck/head lengths.
Product
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1108-2019·2019-04-17
Conformis Recalls Two iTotal CR Total Knee Replacement Systems
Conformis, Inc. is recalling two iTotal CR Total Knee Replacement Systems prepared with incorrect patient ID labels and potentially incorrect components.
Product
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disabil
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1079-2019·2019-04-10
Conformis Recalls Two iTotal Knee Replacement Systems for Labeling Errors
Conformis, Inc. is recalling two iTotal Posterior Stabilized Knee Replacement Systems because the box and sterile pouch labels did not match the contents.
Product
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0731-2019·2019-01-23
Conformis iTotal Hip Replacement System Reamed with Incorrect Interference Fit
Conformis, Inc. is recalling one iTotal Hip Replacement System because the reamer instruments used had a -1mm interference fit instead of the expected -2mm.
Product
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0600-2018·2018-02-21
ConforMIS Recalls Mislabeled Total Knee Replacement Implant Kits
ConforMIS, Inc. is recalling two total knee replacement kits due to mislabeling. The affected units were distributed in California and Texas.
Product
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0991-2017·2017-01-18
ConforMIS iTotal PS Knee Implant Recalled for Software Measurement Error
ConforMIS is recalling iTotal PS Knee Replacement Kits because the iView software displayed femoral cut measurements in the wrong unit.
Product
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS 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
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0658-2017·2016-12-07
ConforMIS iTotal Knee Replacement System Recalled for Incorrect Serial Number Labeling
ConforMIS is recalling two sterile iTotal Knee Replacement Systems distributed to Colorado and Nevada due to incorrect serial numbers on the F4 A/P cut guide iJig.
Product
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1070-2016·2016-03-16
Conformis iTotal Knee Replacement System Recalled for Incorrect Component
ConforMIS, Inc. is recalling a specific unit of the iTotal Cruciate Retaining Knee Replacement System because an incorrect femoral component was distributed.
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0138-2016·2015-10-28
ConForMIS iUni Knee Replacement System Recalled for Ethylene Glycol Residue
ConForMIS is recalling 7 units of the iUni Unicondylar Knee Replacement System due to potential small amounts of ethylene glycol residue.
Product
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0148-2016·2015-10-28
ConFormis iDUO G2 Knee Implant Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling one unit of the ConFormis iDUO G2 knee implant due to potential ethylene glycol residue.
Product
ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0141-2016·2015-10-28
ConForMIS iUni Knee Replacement Recalled for Ethylene Glycol Residue
ConForMIS is recalling 68 iUni Unicondylar Knee Replacement Systems due to potential small amounts of ethylene glycol residue.
Product
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0142-2016·2015-10-28
ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue
ConForMIS is recalling iDuo Bicompartmental Knee Replacement Systems due to potential small amounts of ethylene glycol residue.
Product
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
Category
Medical Device
Distribution
Distributed nationwide