The Spectra-System Dental Implant 2008 system is comprised of dental… — Class II medical device recall Z-1267-2016
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2016-04-06, distributed nationwide. Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receiv
| Recall number | Z-1267-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA, United States |
| Recall initiated | 2016-03-04 |
| Classified | 2016-03-28 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2016-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DO, HN |
| Quantity | 2,033 |
| Lot numbers | 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407, 60158 |
| Model numbers | 423011, 423013, 424708, 424710, 424713, 433010, 433710 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1267-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.