ConforMIS, Inc.: 34 FDA recall reports
Every medical device recall the FDA has published for ConforMIS, Inc.. The fault, and how the agency graded it.
34Reports
0Class I
4Ongoing
2025-04-23Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular
Z-1569-2025 · Class II · reported 2025-04-23 · Ongoing
- Why it was recalled
- The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
- Product
- restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
- Where it went
- US Nationwide distribution in the states of CA, FL, NV, TN.
- How much
- 16
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Z-1591-2024 · Class II · reported 2024-04-24 · Ongoing
- Why it was recalled
- Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
- Product
- Identity Imprint PS Tibial Tray Size 4: Lot 540287
- Where it went
- US Nationwide distribution in the states of FL, KS and NH.
- How much
- 3 units
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Z-2405-2023 · Class II · reported 2023-08-23 · Ongoing
- Why it was recalled
- 30mm screws were labeled as 25mm screws.
- Product
- CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
- Where it went
- US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
- How much
- 25 units
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Z-1133-2023 · Class II · reported 2023-02-22 · Ongoing
- Why it was recalled
- Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
- Product
- iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
- Where it went
- US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA, MA, MD, MS, NE, NH, NV, NY, OH, TN, WI, WY.
- How much
- 70
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Z-0899-2022 · Class II · reported 2022-04-20 · Completed
- Why it was recalled
- Incorrect tibial base plate implant packaged in kit
- Product
- iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
- Where it went
- MS
- How much
- 1 unit
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard
Z-0475-2021 · Class II · reported 2020-12-02 · Terminated
- Why it was recalled
- Incorrect hip components were provided in 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.
- Where it went
- US Distribution in CA.
- How much
- 2
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102
Z-2849-2020 · Class II · reported 2020-09-02 · Terminated
- Why it was recalled
- Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
- Product
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
- Where it went
- NV
- How much
- 1 kit
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product U
Z-1628-2020 · Class II · reported 2020-04-08 · Terminated
- Why it was recalled
- A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
- 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 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.
- Where it went
- US Nationwide distribution in the states of LA, NY, TN.
- How much
- 2
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Prod
Z-1627-2020 · Class II · reported 2020-04-08 · Terminated
- Why it was recalled
- A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
- 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 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.
- Where it went
- US Nationwide distribution in the states of LA, NY, TN.
- How much
- 4
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Repla
Z-0672-2020 · Class II · reported 2019-12-18 · Terminated
- Why it was recalled
- Medial and lateral 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 prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
- Where it went
- US Nationwide distribution in the state of GA.
- How much
- 1 unit
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Z-0063-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- Product
- iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
- Where it went
- Distributed to consignees in MD and NV.
- How much
- 1
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Z-0064-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- Product
- iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
- Where it went
- Distributed to consignees in MD and NV.
- How much
- 1
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Z-1775-2019 · Class II · reported 2019-06-19 · Terminated
- Why it was recalled
- Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
- Product
- Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
- Where it went
- Nationwide
- How much
- 128
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Z-1776-2019 · Class II · reported 2019-06-19 · Terminated
- Why it was recalled
- Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
- Product
- Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
- Where it went
- Nationwide
- How much
- 183
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725IN
Z-1108-2019 · Class II · reported 2019-04-17 · Terminated
- Why it was recalled
- The kits were prepared with incorrect patient ID labels and may contain 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 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.
- Where it went
- Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
- How much
- 2
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Z-1079-2019 · Class II · reported 2019-04-10 · Terminated
- Why it was recalled
- The labeling of the boxes and sterile pouches did not match the contents.
- Product
- iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
- Where it went
- The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
- How much
- 2
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Z-0731-2019 · Class II · reported 2019-01-23 · Terminated
- Why it was recalled
- The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
- Product
- iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
- Where it went
- The products were distributed to the following US states: TN.
- How much
- 1
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS
Z-0600-2018 · Class II · reported 2018-02-21 · Terminated
- Why it was recalled
- Implant kit mislabeled
- Product
- Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+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 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.
- Where it went
- US Distribution to the states of :CA and TX.
- How much
- 2 units
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement Syst
Z-0991-2017 · Class II · reported 2017-01-18 · Terminated
- Why it was recalled
- iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
- 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 device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
- Where it went
- Distribution to TX only
- How much
- 1 unit
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. In
Z-0658-2017 · Class II · reported 2016-12-07 · Terminated
- Why it was recalled
- Mislabeled: incorrect serial number 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.
- Where it went
- Distributed to the states of CO and NV.
- How much
- 2 units
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Z-1070-2016 · Class II · reported 2016-03-16 · Terminated
- Why it was recalled
- Incorrect femoral component distributed
- Product
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
- Where it went
- KY
- How much
- 1 unit
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US
Z-0138-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- 7 units
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US)
Z-0146-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- 348 units
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US)
Z-0141-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- 68 units
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US
Z-0140-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- 6 units
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
Z-0142-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- N/A
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M5723060
Z-0143-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- 12 units
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTA
Z-0147-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- 110 units
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M572506
Z-0145-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- 313 units
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - I
Z-0144-2016 · Class II · reported 2015-10-28 · Terminated
- Why it was recalled
- May contain small amounts of ethylene glycol residue
- Product
- ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
- Where it went
- Distributed Nationwide and in Germany, Switzerland, and UK.
- How much
- 3 units
Showing the 30 most recent of 34. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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