Bacterin OsteoSelect DBM Putty Recalled for Unvalidated Testing Procedure
Bacterin International is recalling 165 units of OsteoSelect DBM Putty because the firm's retesting procedure was not validated.
What this means for you
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: The recall is classified as FDA Class II, but the source text cites a procedural failure (unvalidated retesting) rather than a specific product defect or reported injury, aligning with a moderate severity assessment for a voluntary precautionary recall.
Plain-English summary
Bacterin International, Inc. is recalling 165 units of OsteoSelect DBM Putty, an orthopedic bone filler. The recall was initiated because the firm's retesting procedure was not validated.
The affected product is identified by codes B100164 and B110115. The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
- Manufacturer
- Bacterin International, Inc.
- Hazard
- Affected units
- 165
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 (1)
- B100164 and B110115
Distribution
Distributed nationwide across the United States.
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