• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall INFINITY Internal Hex Healing Abutment

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall INFINITY Internal Hex Healing Abutmentsee related information
Date Initiated by FirmFebruary 22, 2017
Date PostedApril 17, 2017
Recall Status1 Terminated 3 on August 07, 2017
Recall NumberZ-1835-2017
Recall Event ID 76604
510(K)NumberK093518 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductINFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
Code Information Lot Number: 16100050
Recalling Firm/
Manufacturer
Ace Surgical Supply Co., Inc.
1034 Pearl St
Brockton MA 02301-5411
For Additional Information ContactDoreen Price
800-441-3100 Ext. 208
Manufacturer Reason
for Recall
Incorrect device was packaged.
FDA Determined
Cause 2
Labeling mix-ups
ActionACE sent a Customer Notice letter dated February 22, 2017 via certified mail to customers. The letter identified the affected product, problem, risk to health and actions to be taken. Customers were instructed to complete and return the enclosed Business Reply Form. For question call 1-800-441-3100 ext. 208.
Quantity in Commerce87
DistributionNationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
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
-
-