Conformis, Inc.
United StatesFDA applicant, unverified FDA FEI 3004153240
- Devices
- 1,943
- Registrations
- FDA
- FDA recalls
- 374 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Conformis, Inc. makes
Conformis, Inc. manufactures orthopedic joint replacement systems, including total knee and hip prostheses, tibial inserts, acetabular liners, femoral stems, and related implantation instruments such as positioning guides and reamers. Their product portfolio includes patient-specific and standard implant systems like the iTotal® Hip Replacement System, Identity Imprint Knee Replacement System, and ACTERA. The company produces both single-use implantation kits and reusable surgical instruments for joint procedures.
These devices are classified as Class I and Class II medical devices and are listed in the FDA’s Global Unique Device Identification Database (FDA UDI). Conformis, Inc. is based in the United States.
Catalogue
Search and filter all 1,943 devicesShowing 1-50 of 1,943
Company details
- FDA FEI number
- 3004153240
- DUNS number
- 808821883
- Address
- 600 Research Dr, Wilmington, MA, 01887
- Phone
- 781-345-9001
FDA recalls
FDA recall records list 37 recalls initiated by Conformis, Inc., the earliest on 2009-04-23 and the most recent on 2025-03-25. By recorded status: 4 ongoing, 32 terminated and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 2
- 2019 6
- 2020 4
- 2021 0
- 2022 2
- 2023 1
- 2024 1
- 2025 1
- 2026 0
2025
- 25 Mar 2025 Z-1569-2025 Class II Ongoing 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.
2024
- 11 Mar 2024 Z-1591-2024 Class II Ongoing 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.
2023
- 16 Jun 2023 Z-2405-2023 Class II Ongoing 30mm screws were labeled as 25mm screws.
2022
- 14 Nov 2022 Z-1133-2023 Class II Ongoing 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.
- 22 Feb 2022 Z-0899-2022 Class II Completed Incorrect tibial base plate implant packaged in kit
2020
- 21 Sep 2020 Z-0475-2021 Class II Terminated Incorrect hip components were provided in kits.
- 20 Jul 2020 Z-2849-2020 Class II Terminated Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
- 3 Feb 2020 Z-1627-2020 Class II Terminated A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
- 3 Feb 2020 Z-1628-2020 Class II Terminated A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
2019
- 25 Oct 2019 Z-0672-2020 Class II Terminated Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Show the 25 most recent of 37 recalls
2019
- 22 Aug 2019 Z-0063-2020 Class II Terminated Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- 22 Aug 2019 Z-0064-2020 Class II Terminated Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- 29 Mar 2019 Z-1775-2019 Class II 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.
- 29 Mar 2019 Z-1776-2019 Class II 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.
- 4 Jan 2019 Z-1079-2019 Class II Terminated The labeling of the boxes and sterile pouches did not match the contents.
Full distribution text
2018
- 3 Dec 2018 Z-1108-2019 Class II Terminated The kits were prepared with incorrect patient ID labels and may contain incorrect components.
- 16 Oct 2018 Z-0731-2019 Class II 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.
2017
- 24 Jul 2017 Z-0600-2018 Class II Terminated Implant kit mislabeled
2016
- 31 Oct 2016 Z-0991-2017 Class II Terminated iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
- 18 Oct 2016 Z-0658-2017 Class II Terminated Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
- 28 Jan 2016 Z-1070-2016 Class II Terminated Incorrect femoral component distributed
2015
- 31 Aug 2015 Z-0138-2016 Class II Terminated May contain small amounts of ethylene glycol residue
- 31 Aug 2015 Z-0139-2016 Class II Terminated May contain small amounts of ethylene glycol residue
- 31 Aug 2015 Z-0140-2016 Class II Terminated May contain small amounts of ethylene glycol residue
- 31 Aug 2015 Z-0141-2016 Class II Terminated May contain small amounts of ethylene glycol residue
Frequently asked questions
How many devices does Conformis, Inc. have in the registry?
The registry currently lists 1943 devices for Conformis, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Conformis, Inc.'s devices?
Among its 50 most recently registered devices, Conformis, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Conformis, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Conformis, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Conformis, Inc.?
FDA recall records list 37 recalls initiated by Conformis, Inc., the most recent initiated on 25 Mar 2025. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Conformis, Inc. in the registry?
The most recently registered devices listed for Conformis, Inc. include Conformis Hip System 1080-560, ACTERA HES-034-0002-01, Identity Imprint Knee Replacement System TCR030063N01 and iTotal® Hip Replacement System HAR000S24501.