BioHorizons Recalls Titanium Tack Starter Kits Due to Cleaning Instructions
BioHorizons is recalling 1,246 units of Titanium Tack Starter Kits because the provided cleaning instructions may not remove residual contaminants after surgical use.
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 3/5 (High).
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed adverse events.
Plain-English summary
BioHorizons Implant Systems Inc is recalling 1,246 units of the Titanium Tack Starter Kit (REF 400-270). The product is a non-sterile, prescription-only dental device distributed nationwide in the United States and in numerous countries worldwide.
The recall was initiated because the cleaning instructions provided with the device may not be sufficient to remove residual contaminants after surgical use. This issue could potentially affect the safety of the device if not properly addressed.
Healthcare professionals and patients who have used or possess these specific kits should contact BioHorizons Implant Systems Inc for further instructions on how to proceed. The recall covers specific lot numbers listed in the official FDA record.
The recalled product
- Product
- Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
- Manufacturer
- BioHorizons Implant Systems Inc
- Category
- Medical Device — Dental
- Hazard
- Affected units
- 1,246
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)
- Lot Numbers: K0207015
- K0307007
- K0407011
- K0507007
- K0507008
- K0507010
- K0607003
- K0607008
- K0607009
- K0607017
- K0707010
- K0707014
- K0907001
- K0907009
- K0907011
- K1007006
- K1007007
- K1007008
- K1107009
- K1107010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by BioHorizons Implant Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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