OsteoCove and Cove Putty bone graft substitutes recalled for hydration defect
IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty bone graft substitutes due to a hydration issue related to a polymer defect. The affected products are less cohesive and moldable than intended.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall with no reported injuries or hospitalizations. The defect—reduced cohesiveness and moldability due to a polymer issue—represents a risk-of-harm product where injury has not yet been reported, meeting the criterion for a High severity score.
Plain-English summary
IsoTis OrthoBiologics, Inc. is recalling OsteoCove Putty (1.25cc, REF 56920013) and Cove Putty (1.25cc, REF 02-9200-01) bone graft substitute medical devices. Approximately 145 units were distributed nationwide in Alabama, California, Maryland, Minnesota, Mississippi, North Carolina, Nevada, Ohio, Oklahoma, and Texas.
The recall is due to a hydration issue caused by a polymer defect that results in the product being less cohesive and moldable than intended.
Patients and healthcare providers who received affected units should contact IsoTis OrthoBiologics, Inc. for further instructions regarding return of the products.
The recalled product
- Product
- OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
- Manufacturer
- IsoTis OrthoBiologics, Inc.
- Hazard
- device-defect
- hydration-issue
- polymer-issue
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
Distributed nationwide across the United States.
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