Conformis Inc.
34 recalls on record · Latest: Apr 23, 2025
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Agency notice ledger
Federal filing book Conformis Inc. MID-BOOK · SINGLE-AGENCY
#494 of 14,151 · 34 notices · 0.033% archive
- BOOK 34 notices
- RANK #494 of 14,151
- SHARE 0.033% archive
- AGENCY FDA Devices (34)
- CAT medical devices
- CATS 1 category
- LATEST Apr 23, 2025
- PHOTO Colonia Care Pharmacy
Nearest notice-volume peer: Colonia Care Pharmacy (0 notice gap)
Conformis Inc. accounts for about 0.033% of the 104,423-notice archive on 34 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Conformis Inc.'s standing among 14,151 recalling firms
Conformis Inc. ranks 494th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Conformis Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
34 494th of 14151 higher than 13,651 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Conformis Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Conformis Inc. (this)
Conformis Inc.
34 notices
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Colonia Care Pharmacy
34 notices
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34 notices
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Macleods Pharma USA, INC
34 notices
- Orthofix Srl
Orthofix Srl
34 notices
- Sentara Enter…
Sentara Enterprises
34 notices
What this shows Conformis Inc. holds about 0.033% of archive notices alongside 34 distinct filings.
FDA Devices Moderate Apr 23, 2025
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
FDA Devices Moderate Apr 24, 2024
Identity Imprint PS Tibial Tray Size 4: Lot 540287
FDA Devices Moderate Aug 23, 2023
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
FDA Devices Moderate Feb 22, 2023
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
FDA Devices Moderate Apr 20, 2022
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
FDA Devices Moderate Dec 2, 2020
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.
FDA Devices Moderate Sep 2, 2020
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
FDA Devices Moderate Apr 8, 2020
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.
FDA Devices Moderate Apr 8, 2020
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 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.
FDA Devices Moderate Dec 18, 2019
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 prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
FDA Devices Moderate Oct 16, 2019
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
FDA Devices Moderate Oct 16, 2019
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
FDA Devices Moderate Jun 19, 2019
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
FDA Devices Moderate Jun 19, 2019
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
FDA Devices Moderate Apr 17, 2019
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 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.
FDA Devices Moderate Apr 10, 2019
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
FDA Devices Moderate Jan 23, 2019
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
FDA Devices Moderate Feb 21, 2018
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 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.
FDA Devices Moderate Jan 18, 2017
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 device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
FDA Devices Moderate Dec 7, 2016
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.
FDA Devices Moderate Mar 16, 2016
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
FDA Devices Moderate Oct 28, 2015
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
FDA Devices Moderate Oct 28, 2015
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
FDA Devices Moderate Oct 28, 2015
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
FDA Devices Moderate Oct 28, 2015
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
FDA Devices Moderate Oct 28, 2015
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
FDA Devices Moderate Oct 28, 2015
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
FDA Devices Moderate Oct 28, 2015
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
FDA Devices Moderate Oct 28, 2015
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
FDA Devices Moderate Oct 28, 2015
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
FDA Devices Moderate Oct 28, 2015
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
FDA Devices Moderate Oct 28, 2015
ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
FDA Devices Moderate Dec 17, 2014
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
FDA Devices Moderate Aug 29, 2012
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) 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, patello-femoral or
Conformis Inc. holds a measurable archive slice
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (34 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Conformis Inc.? ▼
PlainRecalls indexes 34 distinct federal recall events naming Conformis Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Conformis Inc. sit among other recalling firms? ▼
Conformis Inc. ranks #494 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Conformis Inc.'s notices? ▼
FDA Devices accounts for 34 of this firm's 34 indexed notices.
What product category dominates Conformis Inc.'s filing book? ▼
Filings for Conformis Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Conformis Inc.: 34 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Conformis Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026