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Sign in to claim this brandConformis, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 600 Research Dr, Wilmington, MA, 01887
- Website
- conformis.com
- —
- —
- [email protected]
- Phone
- 781-345-9001
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3004153240
- DUNS Number
- 808821883
Catalogue (1943)
Page 30 of 39| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Conformis Hip System | 1080-604 | FDA UDI | Class I | Active |
| Identity Imprint Knee Replacement System | TCR020074N01 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TCR030073S01 | FDA UDI | Class II | Active |
| iTotal Identity CR Knee Replacement System (with CS Insert) | RCR013120G11 | FDA UDI | Class II | Active |
| Actera | HES-034-0000-01 | FDA UDI | Class II | Active |
| iDuo® iPoly™ Insert Kit | RBK010060002 | FDA UDI | Class II | Active |
| iTotal Identity CR Knee Replacement System (with CS Insert) | RCR013200R01 | FDA UDI | Class II | Active |
| ITotal Identity CR Knee Replacement System | RCR010000G04 | FDA UDI | Class II | Active |
| Identity Imprint | TCR-033-182S-01 | FDA UDI | Class II | Active |
| iTotal® CR iPoly® Insert Kit | RCR010000H13 | FDA UDI | Class II | Active |
| iTotal® Hip Replacement System | HDL060E34S01 | FDA UDI | Class II | Active |
| iTotal Identity CR Knee Replacement System (with CS Insert) | RCR013160L11 | FDA UDI | Class II | Active |
| Identity Imprint | TCR-033-142S-01 | FDA UDI | Class II | Active |
| Identity Imprint | TCR-023-075S-01 | FDA UDI | Class II | Active |
| iUni® iPoly™ Insert Kit | RUK010060002 | FDA UDI | Class II | Active |
| iTotal Identity CR | RCR020000E14 | FDA UDI | Class II | Active |
| Triathlon AS-1 PS Box Chisel Cemented Instrumentation Kit | 6556C00701 | FDA UDI | Class II | Active |
| iTotal® Identity Cruciate Retaining Knee Replacement System | TCR000SPEC01 | FDA UDI | Class II | Unknown |
| Itotal Identity Medium Keel Punch | 1080-220 | FDA UDI | Class II | Active |
| iTotal® CR iPoly® Insert Kit | RCR010000F13 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TCR030147S01 | FDA UDI | Class II | Active |
| Identity Imprint | TCR-033-075N-01 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TPS020104N01 | FDA UDI | Class II | Active |
| iTotal® iPoly XE™ Patella | PAT021350701 | FDA UDI | Class II | Active |
| Identity Imprint | TCR-033-065N-01 | FDA UDI | Class II | Active |
| iTotal Identity CR Knee Replacement System (with CS Insert) | TCR013080C01 | FDA UDI | Class II | Active |
| Conformis Hip System | HCC032B04701 | FDA UDI | Class II | Active |
| iTotal Identity CR | RCR020200R01 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TCR020063S01 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TCR020161S01 | FDA UDI | Class II | Active |
| Itotal Identity Tibial Extension Wrench | 1080-211 | FDA UDI | Class II | Active |
| Identity Imprint Porous CR | TCR-102-F03N-01 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TCR030162N01 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TCR030164N01 | FDA UDI | Class II | Active |
| iTotal Identity CR | RCR020160014 | FDA UDI | Class II | Active |
| iTotal® PS iPoly® XE Insert Kit | RPS020160002 | FDA UDI | Class II | Active |
| Identity Imprint | TCR-033-185S-01 | FDA UDI | Class II | Active |
| iTotal Identity CR | RCR010110004 | FDA UDI | Class II | Active |
| iTotal® Identity Cruciate Retaining Knee Replacement System | RCR010120014 | FDA UDI | Class II | Active |
| iTotal® PS iPoly™ Insert Kit | RPS010120001 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TCR000D00201 | FDA UDI | Class II | Active |
| Identity Imprint | TCR-033-102S-01 | FDA UDI | Class II | Active |
| Actera Hip Stem | HES-034-09CS-01 | FDA UDI | Class II | Active |
| iTotal Identity CR | RCR020000F14 | FDA UDI | Class II | Active |
| Identity Imprint Knee Replacement System | TPS020077S01 | FDA UDI | Class II | Active |
| iTotal® Hip Replacement System | HCC032000001 | FDA UDI | Class II | Unknown |
| iTotal Identity Posterior Stabilized Knee Replacement System | RPS010210003 | FDA UDI | Class II | Active |
| Conformis Hip System | HBS033C15201 | FDA UDI | Class II | Active |
| iDuo® Patella | PAB011380802 | FDA UDI | Class II | Unknown |
| iTotal® CR iPoly XE™ Insert Kit | RCR020000B01 | FDA UDI | Class II | Unknown |
Related Companies
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Authorities
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FDA Recalls (37)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 25, 2025 | Z-1569-2025 | — | open, classified | 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. |
| Mar 11, 2024 | Z-1591-2024 | — | open, classified | 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. |
| Jun 16, 2023 | Z-2405-2023 | — | open, classified | 30mm screws were labeled as 25mm screws. |
| Nov 14, 2022 | Z-1133-2023 | — | open, classified | 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. |
| Feb 22, 2022 | Z-0899-2022 | — | completed | Incorrect tibial base plate implant packaged in kit |
| Sep 21, 2020 | Z-0475-2021 | — | terminated | Incorrect hip components were provided in kits. |
| Jul 20, 2020 | Z-2849-2020 | — | terminated | Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920 |
| Feb 3, 2020 | Z-1627-2020 | — | terminated | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. |
| Feb 3, 2020 | Z-1628-2020 | — | terminated | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. |
| Oct 25, 2019 | Z-0672-2020 | — | terminated | Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. |
| Aug 22, 2019 | Z-0064-2020 | — | terminated | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. |
| Aug 22, 2019 | Z-0063-2020 | — | terminated | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. |
| Mar 29, 2019 | Z-1775-2019 | — | terminated | 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. |
| Mar 29, 2019 | Z-1776-2019 | — | terminated | 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. |
| Jan 4, 2019 | Z-1079-2019 | — | terminated | The labeling of the boxes and sterile pouches did not match the contents. |
| Dec 3, 2018 | Z-1108-2019 | — | terminated | The kits were prepared with incorrect patient ID labels and may contain incorrect components. |
| Oct 16, 2018 | Z-0731-2019 | — | terminated | 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. |
| Jul 24, 2017 | Z-0600-2018 | — | terminated | Implant kit mislabeled |
| Oct 31, 2016 | Z-0991-2017 | — | terminated | iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). |
| Oct 18, 2016 | Z-0658-2017 | — | terminated | Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. |
| Jan 28, 2016 | Z-1070-2016 | — | terminated | Incorrect femoral component distributed |
| Aug 31, 2015 | Z-0142-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0144-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0145-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0148-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0138-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0141-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0139-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0143-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0140-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0146-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Aug 31, 2015 | Z-0147-2016 | — | terminated | May contain small amounts of ethylene glycol residue |
| Nov 19, 2014 | Z-0581-2015 | — | terminated | Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting |
| Jul 17, 2012 | Z-2222-2012 | — | terminated | Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique |
| Apr 23, 2009 | Z-1624-2009 | — | terminated | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. |
| Apr 23, 2009 | Z-1623-2009 | — | terminated | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. |
| Apr 23, 2009 | Z-1622-2009 | — | terminated | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. |