Conformis recalls iTotal Posterior Stabilized knee replacement systems with mismatched labeling on boxes and pouches. Affected units include specific catalog and serial numbers. Consumers should contact Conformis for details.
The labeling of the boxes and sterile pouches did not match the contents.
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Contact the company
📍Recalling firmConformis, Inc.600 Technology Park Dr · Billerica, MA 01821-4154
✎ GovInfoNow plain-language explainer
Conformis is recalling certain iTotal Posterior Stabilized knee replacement systems due to mismatched labeling on boxes and sterile pouches. This could lead to incorrect surgical procedures if the wrong parts are used. The recall affects specific catalog and serial numbers. Read more at govinfonow.com/recall/69182-conformis-itotal-ps-knee-replacement-system-labeling-mismatch-recall.
“Conformis iTotal PS Knee Replacement System: Labeling Mismatch Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69182-conformis-itotal-ps-knee-replacement-system-labeling-mismatch-recall. Based on FDA recall #Z-1079-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1079-2019%22&limit=1).
The FDA announced on Jan. 4, 2019, that Conformis Inc. voluntarily recalled two iTotal Posterior Stabilized (PS) Knee Replacement Systems due to labeling mismatches between the boxes, sterile pouches, and contents. The recall was classified as Class II.
How to tell if you have it
Brand: Conformis
Product: iTotal Posterior Stabilized (PS) Knee Replacement System
Catalog Number: TPS-111-1111 - 020102
Serial Numbers: 0434436 and 0434836
The hazard
The hazard involves the labeling of the boxes and sterile pouches not matching the contents inside. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Conformis Inc. has had 14 other recalls since July 24, 2017. Recent brand recalls include a March 25, 2025 hip liner labeling error and a March 11, 2024 tibial tray packaging mix-up. Other recent recalls of similar products include an EMPOWR 3D Knee implant labeling notice (Jan. 15, 2026) and an Encore Medical EMPOWR 3D Knee packaging discrepancy risk (Jan. 5, 2026).
How to tell if you have this one
Check for catalog number TPS-111-1111 and serial numbers 0434436 or 0434836 on the product box or sterile pouch. The recall applies to specific units sold with these identifiers.
Brand
Conformis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Conformis
Reach out to Conformis directly for information about the recalled units and next steps.
Where it went and when
Where it was distributed
Distributed in New Hampshire, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Hampshire.
Recall timeline
FDA terminated this recall 18 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-1079-2019 (January 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1079-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.