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U.S. Department of Health and Human Services

Class 2 Device Recall Keystone Dental PrimaConnex Straight Implant TC

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 Class 2 Device Recall Keystone Dental PrimaConnex Straight Implant TCsee related information
Date Initiated by FirmMarch 09, 2017
Date PostedApril 13, 2017
Recall Status1 Terminated 3 on July 05, 2017
Recall NumberZ-1818-2017
Recall Event ID 76782
510(K)NumberK051614 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductKeystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Code Information Lot Number: 30214
Recalling Firm/
Manufacturer
Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact
781-328-3390
Manufacturer Reason
for Recall
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
FDA Determined
Cause 2
Labeling mix-ups
ActionKeystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272
Quantity in Commerce59 units
DistributionCA, IL, IN, FL, MA, MN, NJ, NV, PA,
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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