Howmedica Recalls Cortoss Bone Augmentation Material Due to Temperature Violations
Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material because shipments were transported outside required refrigerated temperature conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential hazards of nerve damage, paralysis, and embolism, which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk medical device defects.
Plain-English summary
Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010. The recall was initiated because shipments of the product were transported outside of the required refrigerated temperature conditions.
The affected lots include A1907006 and A1908003 for Catalog No. 2101-0005, and A1903054 and A1906006 for Catalog No. 2101-0010. The products were distributed to facilities in California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.
The potential hazards associated with using the product include nerve damage resulting in paralysis and an increased potential for embolism. Consumers and healthcare providers should check their inventory for these specific catalog numbers and lot codes and stop using the product if it matches the recalled items.
The recalled product
- Product
- Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 115
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Specific shipments of 2101-0005: Lots A1907006
- A1908003
- 2101-0010: Lots A1903054
- A1906006. UDI 00808232000962
- 00808232000979
Distribution
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