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Conformis, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 600 Research Dr, Wilmington, MA, 01887
Website: conformis.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 781-345-9001
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004153240
DUNS Number: 808821883

Catalogue (1943)

Page 6 of 39

Device	Model / Reference	Registries	Class	Status
Identity Imprint	TCR-033-184S-01	FDA UDI	Class II	Active
Conformis Hip System	1080-601	FDA UDI	Class I	Active
Identity Imprint	TCR-033-121S-01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS020181S01	FDA UDI	Class II	Active
iTotal Identity CR	RCR020110F11	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	RPS020140013	FDA UDI	Class II	Active
iUni® iPoly™ Insert Kit	RUK010080002	FDA UDI	Class II	Active
Actera	HES-034-0007-01	FDA UDI	Class II	Active
Conformis Hip System	HCC032B06101	FDA UDI	Class II	Active
Identity Imprint	TCR-033-107S-01	FDA UDI	Class II	Active
iTotal® Identity Cruciate Retaining Knee Replacement System	RCR010150004	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS030183N01	FDA UDI	Class II	Active
iTotal® CR iPoly™ Insert Kit	RCR010090003	FDA UDI	Class II	Active
iTotal Identity CR Knee Replacement System (with CS Insert)	RCR023170M11	FDA UDI	Class II	Active
iTotal® PS Tibial Keel Punch Tip	1080-552	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR020146N01	FDA UDI	Class II	Active
iTotal Identity CR	RCR010000P04	FDA UDI	Class II	Active
Identity Imprint	TCR-023-187S-01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS030072N01	FDA UDI	Class II	Active
iDuo® Patella Implant Sizer	1080-407	FDA UDI	Class II	Active
iDuo	BKA-111-111102	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS030126N01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS020163N01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR020145S01	FDA UDI	Class II	Active
Patella Clamp Assembly	1080-507	FDA UDI	Class I	Active
iTotal PS	RPS-010-190011	FDA UDI	Class II	Active
Conformis Hip System	1080-114	FDA UDI	Class II	Active
iTotal® PS	RPS010160002	FDA UDI	Class II	Active
Conformis Hip System	1080-581	FDA UDI	Class I	Active
iTotal® Hip Replacement System	HDL060D20L01	FDA UDI	Class II	Active
iTotal® Hip Replacement System	HDL060B14S01	FDA UDI	Class II	Active
Identity Imprint Porous CR	TCR-302-T07S-01	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	RPS020080013	FDA UDI	Class II	Active
iTotal Identity CR Knee Replacement System (with CS Insert)	RCR013160L01	FDA UDI	Class II	Active
Itotal Oval Patella Trial 35mm	1080-203	FDA UDI	Class II	Active
iTotal® CR Tibial Keel Punch Tip	1080-527	FDA UDI	Class II	Active
iDuo® iPoly™ Insert Kit	RBK010120001	FDA UDI	Class II	Unknown
iTotal CR	RCR-020-140003	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS020124S01	FDA UDI	Class II	Active
iTotal PS	RPS-010-150011	FDA UDI	Class II	Active
iUni® iPoly™ Insert Kit	RUK010110002	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR030165N01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR030084N01	FDA UDI	Class II	Active
Conformis Hip System	1080-572	FDA UDI	Class I	Active
Identity Imprint Knee Replacement System	TPS020066N01	FDA UDI	Class II	Active
iTotal® Cruciate Retaining (CR) Knee Replacement System	TCR111111102	FDA UDI	Class II	Active
iTotal® Identity Cruciate Retaining Knee Replacement System	TCR010070001	FDA UDI	Class II	Active
Cordera Hip System	1080-671	FDA UDI	Class I	Active
Conformis Hip System	HBS033C15301	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR030104N01	FDA UDI	Class II	Active

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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.