Recall Z-0562-2013— BioHorizons Implant Systems Inc
Class II · Terminated
Class II FDA medical device recall by BioHorizons Implant Systems Inc, initiated 2012-11-19, terminated 2013-09-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.. Reason: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use..
- Recalling firm
- BioHorizons Implant Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-19
- Terminated
- 2013-09-24
- Firm location
- Birmingham, AL, United States
Product description
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Reason for recall
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.