BioHorizons Dental Implant Recalled Due to Incorrect Length Labeling
BioHorizons is recalling 32 units of 5.0 x 15mm dental implants because the packaging incorrectly listed the length as 10.5mm.
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, and the hazard is a minor labeling error regarding product dimensions without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
BioHorizons Implant Systems Inc is recalling 32 units of RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform dental implants (REF LPBR5015). The recall is due to a labeling error where the implant inner vial packaging incorrectly displayed a length of 10.5mm instead of the specified 15mm.
The affected units are from Lot 1404442. These products were distributed worldwide, including in the United States (California, Colorado, New York, Ohio, Washington, Arizona, Michigan, Maryland, Georgia, and North Carolina) and internationally to Iran.
Healthcare providers should stop using the affected implants and contact BioHorizons for further instructions. Patients who have received these implants should consult their dental provider if they have questions regarding the labeling discrepancy.
The recalled product
- Product
- RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
- Manufacturer
- BioHorizons Implant Systems Inc
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 32
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 1404442
Distribution
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