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Terminated

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

FDA Recall Z-1267-2016 · Posted None

Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2016-03-04
Date Terminated2016-05-17
Product Quantity2033

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.

Firm 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

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090234SPECTRA SYSTEM DENTAL IMPLANTS 2008Implant Direct, LLC · 2009-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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