Bone Graft Putty Recalled for Polymer Hydration Issue Affecting Handling
IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty due to a polymer hydration defect that reduces product cohesiveness and moldability.
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: FDA Class II medical device recall with no reported hospitalizations or injuries. However, the polymer hydration defect compromises the fundamental handling and placement characteristics required for surgical application, classifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
IsoTis OrthoBiologics, Inc. is recalling OsteoCove Putty, 1.25cc (REF 56920013) and Cove Putty, 1.25cc (REF 02-9200-01). These are surgical bone graft materials used in orthopedic procedures.
The recall is due to a hydration issue in the polymer formulation. Affected products have reduced cohesiveness and moldability compared to their intended specifications, which could impact their performance during surgical placement.
Approximately 145 units were distributed nationwide to healthcare facilities in Alabama, California, Maryland, Minnesota, Mississippi, North Carolina, Nevada, Ohio, Oklahoma, and Texas. Specific affected lot numbers and expiration dates have been identified by the manufacturer.
Healthcare providers should immediately discontinue use of the affected lots and contact IsoTis OrthoBiologics for return instructions and product replacement.
The recalled product
- Product
- OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
- Manufacturer
- IsoTis OrthoBiologics, Inc.
- Hazard
- polymer-defect
- reduced-cohesiveness
- handling-defect
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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