FDA Device recall Z-0561-2013
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244 by Biohorizons Implant Systems, citing the cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0561-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-19 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biohorizons Implant Systems |
| Distribution | US |
Product
AutoTac Delivery Handle, REF 400-200, 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.
Identifiers
| code_info | Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 100…Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, and 1202282 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Biohorizons Implant Systems
- 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 - 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 - 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 - 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
All Biohorizons Implant Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0561-2013%22
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