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 A1907006A19080032101-0010: Lots A1903054A1906006. UDI 0080823200096200808232000979
- Specific shipments of 2101-0005
- 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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