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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1605-2015%22
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