FDA Device recall Z-1267-2016
The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece impla…
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece impla… by Implant Direct Sybron Manufacturing, citing implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1267-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-04 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | US |
Product
The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710
Reason
Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.
Identifiers
| code_info | Lot Number: 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407,60158 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1267-2016%22
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