Reported May 13, 2020 · Terminated

Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Howmedica Osteonics Corp.

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: Howmedica Osteonics Corp. · 2 Pearl Ct · Allendale, NJ · 07401-1611

Is this the product you have?

  • Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Lot codes and dates
  • Specific shipments of 2101-0005
    • Lots A1907006
    • A1908003
    • 2101-0010: Lots A1903054
    • A1906006. UDI 00808232000962
    • 00808232000979
Amount recalled
115

Where it was sold

Why it was recalled

Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.

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 Aug 27, 2020 · Data as of Sep 19, 6:13 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.