Z-1267-2016Class II

The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices...

Name: Z-1267-2016 The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2016-03-04
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2016-03-04 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect... on 2016-03-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1267-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-04
Posted: 2016-03-28
Terminated: 2016-05-17
Recalling firm: Implant Direct Sybron Manufacturing LLC
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
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated March 4, 2016, to all affected customers. The letter states that Implant Direct will correct the issue and send the proper tool. The proper tool is included with the notification. The letter requests that customers complete and return the Acknowledgement and Recall Return Form within 48 hours. It customers are an authorized Implant Direct Sybron Manufacturing distributor it is requested that customers are identified and contact them to inform them of the issue within 48 hours of receiving the notification. Distributors should also provide customers with the correct tool. If you have any of the affected product listed above and have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. For further questions regarding this please call (818) 444-3300 Ext. 3323
Quantity in commerce: 2033
Distribution: Worldwide Distribution - Nationwide Distribution to the states of : FL, AZ, IL, MS, TX, CA, ID, AL, MO, MN, NY, CO, GA, ME, NJ, NC, NV, LA, KS, MN, KY, PA, UT, OH, MI, SC, MD, WA, WI., and to the countries of : Canada, Honduras and Dominican Republic.
Product codes and lots: Lot Number: 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407,60158

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1267-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1267-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-28

Product code DZE

K090234Class IISpectra System Dental Implants 2008Implant Direct, LLC / cleared 2009-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)