UnratedMedical device recall · FDA · Published February 22, 2022
Conformis iTotal PS Knee Replacement System Recall: Incorrect Tibial Base Plate Package
Conformis recalls iTotal Identity Posterior Stabilised Knee Replacement System model TPS-301-1113-020101 due to incorrect tibial base plate implant packaging. Affected units have specific serial numbers and UDI codes.
“Conformis iTotal PS Knee Replacement System Recall: Incorrect Tibial Base Plate Package.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61075-conformis-itotal-ps-knee-replacement-system-recall-incorrect-tibial-base. Based on FDA recall #Z-0899-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0899-2022%22&limit=1).
Conformis Inc. voluntarily recalled one iTotal Identity Posterior Stabilised (PS) Knee Replacement System on Feb. 22, 2022, because an incorrect tibial base plate implant was packaged in the kit, according to the FDA.
How to tell if you have it
Brand: Conformis
Product: iTotal Identity Posterior Stabilised (PS) Knee Replacement System
Model Number: TPS-301-1113-020101
Serial Number: 0496242
UDI: M572TPS3011113011
Quantity: 1 unit
Distribution: MS
The hazard
The recall involves an incorrect tibial base plate implant packaged in the kit. The FDA announced the Class II recall on Feb. 22, 2022.
Context
GovInfoNow's records show Conformis Inc. has had 14 other recalls since July 24, 2017. Other recent recalls of similar products include Conformis Hip System Acetabular Liner Recalled Due to Incorrect Labeling (March 25, 2025), Conformis Identity Imprint PS Tibial Tray Size 4 Lot 540287: Packaging Mix-Up Risk (March 11, 2024), and Conformis Hip Screw Recall: 30mm screws labeled as 25mm (June 16, 2023). Other recent recalls of similar products include Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall: Packaging Discrepancy Risk (Jan. 5, 2026), U2 Total Knee System Femoral Valgus Adaptor Recall: Assembly Risk (May 20, 2026), and U2 Total Knee System Femoral Offset Bushing Recall: Incorrect Implant Orientation Risk (March 19, 2026).
How to tell if you have this one
Check for model number TPS-301-1113-020101 on the product packaging. Affected units also have serial number 0496242 and UDI code M572TPS3011113011.
Brand
Conformis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number, serial number, and UDI code on the product packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in Mississippi.
Listed by the agency
Not listed
FDA distribution: “MS” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Mississippi.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0899-2022 (February 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0899-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.