FDA Device recall Z-1605-2015
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
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant… by Biohorizons Implant Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1605-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-16 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biohorizons Implant Systems |
| Distribution | US |
Product
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
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.
Identifiers
| code_info | Lot Number 1501968 |
|---|
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 - 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 - AutoTac Delivery Handle, REF 400-200, 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-1605-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.