RTI Biologics BioSet IC RT Paste Recalled for Incorrect Instructions
RTI Surgical is recalling 24 units of BioSet IC RT Paste due to incorrect instructions for use. The product was distributed in Colombia.
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: The recall is classified as FDA Class II, but the source text explicitly states the issue is incorrect instructions for use with no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
RTI Surgical, Inc. is recalling 24 units of RTI Biologics BioSet IC RT Paste 2 cc. This product is a calcium compound filler used in dental, spine, and orthopedic applications. The recall is being conducted because the product was shipped with incorrect instructions for use (IFU).
The affected units were distributed internationally to Colombia only. Specific serial numbers for the recalled units are listed in the agency's official record. No illnesses or injuries have been reported in connection with this recall.
Healthcare providers and patients who have this product should stop using it and contact RTI Surgical, Inc. for further instructions on how to return or dispose of the units.
The recalled product
- Product
- RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
- Manufacturer
- RTI Surgical, Inc.
- Hazard
- Affected units
- 24
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)
- Serial #'s: 30303308
- 30303321
- 30303327
- 30303340
- 3034313
- 30304314
- 30304330
- 30401686
- 30401699
- 30401714
- 30401721
- 30401723
- 30401730
- 30401732
- 30401735
- 3041741
- 30401746
- 30401750
- 30718244
- 30718441
Distribution
Distribution scope not specified by the agency.
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