Conformis recalls Identity Imprint PS Tibial Tray Size : Lot 540287 due to packaging mix-up between lots 540287 and 508287. This may lead to incorrect product use.
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.
Take action
Contact the company
📍Recalling firmConformis, Inc.600 Technology Park Dr # 400 · Billerica, MA 01821-4154
“Conformis Identity Imprint PS Tibial Tray Size 4 Lot 540287: Packaging Mix-Up Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55939-conformis-identity-imprint-ps-tibial-tray-size-4-lot-540287. Based on FDA recall #Z-1591-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1591-2024%22&limit=1).
Conformis Inc. recalled one Identity Imprint PS Tibial Tray Size 4 (Lot 540287) due to packaging errors, according to the FDA on March 11, 2024. The hazard involves a Size 5 tray being packaged in a Size 4 box.
How to tell if you have it
Brand: Conformis
Product: Identity Imprint PS Tibial Tray Size 4
Lot number: 540287
Catalog Number: TPS-301-T04S
UDI#: M572TPS301T04S011
The hazard
A Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. Conformis confirmed that Lots 540287 and 508287 were swapped between the pouching and final pack stages.
Context
GovInfoNow's records show Conformis Inc. has 14 other recalls on record since July 24, 2017. Recent brand recalls include a March 25, 2025 recall of Hip System Acetabular Liners for incorrect labeling and a June 16, 2023 recall of Hip Screws labeled incorrectly. Other recent recalls of similar products include an Jan. 5, 2026 Encore Medical EMPOWR 3D Knee Tibial Insert packaging discrepancy risk and Feb. 16, 2026 Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE packaging mix-up.
How to tell if you have this one
Check the product's lot number on the box or label. The affected product is Identity Imprint PS Tibial Tray Size 4 with Lot 540287 (Catalog Number: TPS-301-T04S).
Brand
Conformis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot number 540287 on the box or label to confirm if the product is affected.
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 FL, KS and NH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Kansas, New Hampshire.
Recall timeline
FDA published this recall 44 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-1591-2024 (March 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1591-2024 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.