BioHorizons AutoTac Delivery Handle Recalled for Insufficient Cleaning Instructions
BioHorizons is recalling 174 AutoTac Delivery Handles because cleaning instructions may not remove residual contaminants after surgical use.
What this means for you
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 is classified as FDA Class II and involves a risk-of-harm product (residual contaminants) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
BioHorizons Implant Systems Inc is recalling 174 units of the AutoTac Delivery Handle (REF 400-200). This is a non-sterile, prescription-only dental instrument manufactured in Birmingham, Alabama. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall was initiated because the cleaning instructions provided with the device may not be sufficient to remove residual contaminants after surgical use. The affected units were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Japan.
Dental professionals and patients who have used these specific delivery handles should contact BioHorizons Implant Systems Inc for further instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
- Manufacturer
- BioHorizons Implant Systems Inc
- Affected units
- 174
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: 02070051
- 04070030
- 0800152
- 06070018
- 0801863
- 0802225
- 0802469
- 0900838
- 0901751
- 0902145
- 0902956
- 1000003
- 1001504
- 1004620
- 1101301
- 1101802
- 1103359
- 1104032
- 1104976
- 1200616
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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