BioHorizons Recalls Tapered HD Upgrade Set Due to Incorrect Drill Component
BioHorizons is recalling 48 units of the Tapered HD Upgrade Set because they were packaged with a stainless steel drill instead of the correct titanium component.
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. The hazard involves a material substitution (stainless steel instead of titanium) in a surgical instrument, which is a significant quality defect but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).
Plain-English summary
BioHorizons Implant Systems Inc is recalling 48 units of the Tapered HD Upgrade Set (REF TSKHDUS, Lot Number 1501968). These are non-sterile, prescription-only surgical instruments used in preparation for dental implant placement.
The recall was initiated because the sets were packaged with an incorrect drill component. The included drill was manufactured from stainless steel rather than the correct titanium material.
The affected products were distributed nationwide in the states of Alabama, Florida, Mississippi, Virginia, Louisiana, California, North Carolina, Texas, Tennessee, Ohio, Oklahoma, Vermont, Washington, Maryland, New York, South Dakota, and South Carolina. Consumers and healthcare providers should stop using these products and contact BioHorizons for further instructions.
The recalled product
- Product
- Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
- Manufacturer
- BioHorizons Implant Systems Inc
- Affected units
- 48
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)
- Lot Number 1501968
Distribution
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