Howmedica Osteonics Corp.: Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Is my product affected?

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

• UPC 00808232000962
• UPC 00808232000979

Check against the official notice below — it lists the full affected range.

What happened

Howmedica Osteonics Corp. is recalling Cortoss Bone Augmentation Material (catalog numbers 2101-0005 and 2101-0010) because certain shipments were transported outside required refrigerated temperature conditions. The affected lots are A1907006 and A1908003 for catalog number 2101-0005, and A1903054 and A1906006 for catalog number 2101-0010. A total of 115 units were distributed across the United States to California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.

If this product is used after being exposed to improper temperature conditions, potential hazards include nerve damage resulting in paralysis and increased potential for embolism. The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin Quantity: 115 Lot/code info: Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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