Lower riskMedical device recall · FDA · Published February 3, 2020
Conformis iTotal PS Knee Replacement System: Incorrect Serial Number Delivery
Conformis recalls a limited number of iTotal PS knee replacement systems with incorrect serial numbers delivered to the wrong customers. This does not pose a safety risk but requires correction of labeling.
“Conformis iTotal PS Knee Replacement System: Incorrect Serial Number Delivery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65909-conformis-itotal-ps-knee-replacement-system-incorrect-serial-number-delivery. Based on FDA recall #Z-1628-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1628-2020%22&limit=1).
Conformis Inc. recalled 2 iTotal PS Knee Replacement Systems on Feb. 3, 2020, after tibial trays were labeled with incorrect serial numbers and delivered to wrong customer accounts, the FDA said.
How to tell if you have it
Brand: Conformis
Product: iTotal PS Knee Replacement System
Model No.: TPS-111-1111-010101
Description: ITOTAL PS IPOLY IMPLANT KIT LEFT
Lot codes: 0460018, 0460118
Quantity: 2 units
Distribution: US Nationwide in LA, NY, TN
The hazard
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Context
GovInfoNow's records show Conformis Inc. has 14 other recalls on record since July 24, 2017. Other recent recalls of similar products include Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (Jan. 5, 2026), Onkos My3D Pelvic Implant Recalled Due to Wrong Customer Distribution (July 24, 2026), and EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026).
How to tell if you have this one
Check for the model number TPS-111-1111-010101 on the iTotal PS Knee Replacement System (left side). The product was delivered to the wrong customer accounts due to an incorrect serial number label.
Brand
Conformis
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of LA, NY, TN.
Recall number
Product, codes & lots
Quantity
Z-1627-2020
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.; 0454572 0454472 0459726 0449726
4
Z-1628-2020
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.; 0460018 0460118
2
Based on the official FDA remedy
What to do — step by step
Verify Product Label
Check the model number on the product to confirm it is TPS-111-1111-010101.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of LA, NY, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Louisiana, New York, Tennessee.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1628-2020 (February 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1628-2020 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.