OsteoCove and Cove Putty bone void fillers recalled due to hydration defect
IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty bone graft materials due to a hydration issue that makes the product less cohesive and moldable than intended.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text explicitly states only a functional defect (reduced cohesiveness and moldability) with no reported illnesses, injuries, or hospitalizations, meeting the criteria for Moderate severity.
Plain-English summary
IsoTis OrthoBiologics, Inc. is recalling OsteoCove Putty (1.25cc, REF 56920013) and Cove Putty (1.25cc, REF 02-9200-01) due to a hydration issue resulting from a polymer problem. The defect causes the products to be less cohesive and moldable than intended.
A total of 145 units have been distributed nationwide to healthcare facilities in Alabama, California, Maryland, Minnesota, Mississippi, North Carolina, Nevada, Ohio, Oklahoma, and Texas. The affected OsteoCove Putty lot numbers are 180054, 180054R18, 179604R18, 180484, 180370, 180299, and 180075. The affected Cove Putty lot number is 180075R18.
Consumers and healthcare providers who have received these products should contact IsoTis OrthoBiologics, Inc. for further instructions regarding the recalled units.
The recalled product
- Product
- OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
- Manufacturer
- IsoTis OrthoBiologics, Inc.
- Affected units
- 145
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 (20)
- OsteoCove Putty
- REF 56920013
- UDI-DI: 10889981309022
- Lot Numbers: 180054
- Exp. 2025-08-28
- 180054R18
- 179604R18
- Exp. 2024-12-28
- 180484
- Exp. 2026-02-28
- 180370
- Exp. 2026-01-28
- 180299
- Exp. 2025-11-28
- 180075
- and Cove Putty
- REF 02-9200-013
- UDI-DI: 10889981308933
- Lot Number: 180075R18
- Exp. 2025-08-28.
Distribution
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