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U.S. Department of Health and Human Services

Class 2 Device Recall GoDirect

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 Class 2 Device Recall GoDirectsee related information
Date Initiated by FirmMarch 04, 2016
Create DateMarch 28, 2016
Recall Status1 Terminated 3 on May 17, 2016
Recall NumberZ-1267-2016
Recall Event ID 73448
510(K)NumberK090234 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductThe 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
Code Information Lot Number: 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407,60158
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact
818-444-3300 Ext. 3323
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionImplant 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 Commerce2033
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DZE
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