--- title: "Conformis, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Conformis, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/conformis-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Conformis, Inc. recall records **4** reported ongoing 5 records in this archive. Latest source date Mar 25, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Mar 25, 2025 FDA device enforcement ### [restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System](https://isitonrecall.com/recall/fda-device-z-1569-2025-restor3d-cordera-hip-system-acetabular-liner-grp-c-36mm-lip-model-number-hdl-060-c22l-000101-acetabu/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, FL, NV, TN. [Official source for restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 A...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1569-2025%22) Mar 11, 2024 FDA device enforcement ### [Identity Imprint PS Tibial Tray Size 4: Lot 540287](https://isitonrecall.com/recall/fda-device-z-1591-2024-identity-imprint-ps-tibial-tray-size-4-lot-540287/) 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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, KS and NH. [Official source for Identity Imprint PS Tibial Tray Size 4: Lot 540287](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1591-2024%22) Jun 16, 2023 FDA device enforcement ### [CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO](https://isitonrecall.com/recall/fda-device-z-2405-2023-conformis-hip-screw-6-5mm-x-25mm-sterile-eo/) 30mm screws were labeled as 25mm screws. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA. [Official source for CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2405-2023%22) Nov 14, 2022 FDA device enforcement ### [iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE](https://isitonrecall.com/recall/fda-device-z-1133-2023-itotal-identity-impactor-handle-model-no-1080-212-ed-07827-rev-ae/) 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. Class II Reported ongoing Distribution: 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. [Official source for iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1133-2023%22) Feb 22, 2022 FDA device enforcement ### [iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101](https://isitonrecall.com/recall/fda-device-z-0899-2022-itotal-identity-posterior-stabilised-ps-knee-replacement-system-model-number-tps-301-1113-020101/) Incorrect tibial base plate implant packaged in kit Class II Reported completed Distribution: MS [Official source for iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0899-2022%22) ## Reasons in these listed records - 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. - 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. - 30mm screws were labeled as 25mm screws. - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Conformis, Inc. ### Is there a recall on conformis, inc. right now? This archive contains 5 records, including 4 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Conformis, Inc.](https://isitonrecall.com/check/?q=Conformis%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)