Biohorizons Implant Systems recalls
Biohorizons Implant Systems appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2015-12-16.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2012-12-26 to 2015-12-16 |
| By agency | FDA Device (5) |
| By classification | Class II (5) |
| By status | terminated (5) |
| Distribution named in notices | AZ, CA, CO, GA, MD, MI, NC, NY, OH, US, WA |
Recalls
- RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
FDA Device · Class II · 2015-12-16 · Biohorizons Implant Systems
Reason: An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. - Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant…
FDA Device · Class II · 2015-05-20 · Biohorizons Implant Systems
Reason: BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium. - External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 3…
FDA Device · Class II · 2014-02-26 · Biohorizons Implant Systems
Reason: The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. - Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244
FDA Device · Class II · 2012-12-26 · Biohorizons Implant Systems
Reason: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. - AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244
FDA Device · Class II · 2012-12-26 · Biohorizons Implant Systems
Reason: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.