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U.S. Department of Health and Human Services

Class 3 Device Recall Jet Denture Repair Acrylic

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  Class 3 Device Recall Jet Denture Repair Acrylic see related information
Date Initiated by Firm June 07, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 20, 2004
Recall Number Z-1043-04
Recall Event ID 29304
Product Classification Resin, Denture, Relining, Repairing, Rebasing - Product Code EBI
Product Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package
Code Information product code 1220, box lot 1220-4023, bottle lot 60274005/04AB - clear;  product code 1223, box lot 1223-4024, bottle lot 60274005/04AB -clear and box lot 1223-4025, bottle lot 12163001/01AN - meharry
Recalling Firm/
Manufacturer
Lang Dental Mfg Co, Inc.
175 Messner Dr
Wheeling IL 60090-6433
For Additional Information Contact Ms. Joanne B. Lang
800-222-5264 Ext. 25
Manufacturer Reason
for Recall
The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
FDA Determined
Cause 2
Other
Action Lang Dental sent recall letters dated 6/7/04 to their direct accounts, informing them of the contamination of the acrylic resin powders with the black particles and requesting the return of any existing inventory of the affected lots of product for replacement. Distributors were requested to sub-recall the products from their accounts. Follow-up letters were sent to the accounts on 6/14/04, clarifying the lot numbers affected to include both the lot number on the box and the lot number on the bottom of the squeeze bottles affected.
Quantity in Commerce 27 units
Distribution Nationwide
Total Product Life Cycle TPLC 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.
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