Reported Apr 24, 2024 · Ongoing

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Conformis, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Conformis, Inc. · 600 Technology Park Dr # 400 · Billerica, MA · 01821-4154

Is this the product you have?

  • Identity Imprint PS Tibial Tray Size 4Lot 540287
Lot codes and dates
  • Catalog Number
    • TPS-301-T04S
    • UDI#: M572TPS301T04S011
    • Lot number 540287
Amount recalled
3 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.