Reported Mar 9, 2022 · Terminated

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

Stryker Leibinger GmbH & Co. KG

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: Stryker Leibinger GmbH & Co. KG · Botzinger Str. 41 · Freiburg Im Breisgau · N/A

Is this the product you have?

    • MEDPOR Titan OFW - MTB - Right - 1.0mm
    • Catalog number 81032
Lot codes and dates
  • UDI07613252084334
  • Lot Number3R7YHD
Amount recalled
74

Where it was sold

  • Nationwide

Why it was recalled

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

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

Notice updated Dec 21, 2023 · Data as of Sep 19, 6:53 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.