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U.S. Department of Health and Human Services

Class 3 Device Recall OrthoJet Powder

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  Class 3 Device Recall OrthoJet Powder 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-1042-04
Recall Event ID 29304
Product Classification Crown And Bridge, Temporary, Resin - Product Code EBG
Product Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following brands and sizes:
a.1) Ortho-Jet Powder, Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969, product code 1320, 100 g plastic squeeze bottle;
a.2) Biocryl Resin Acrylic, Great Lakes Orthodontics, Ltd., P.O. Box 5111, Towanda, New York 14151-5111, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle;
b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle;
b.2) Contemporary Colored Assorted Kit, Great Lakes Orthodontics, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit;
c.1) Electric Colored Ortho-Jet Powder, Lang Dental, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit;
c.2) Tropical Tones Acrylic Resin, Great Lakes Orthodontics, product code 045-052, 4 oz. plastic squeeze bottle
Code Information a.1) product code 1320, box lot 1320-4005, bottle lot 60274005/04AB;  a.2) product code 040-016, lot 53-1334-4016, empty bottle and cap only;  b.1) product code 1520, box lot 1520-4020, bottle lot 15144002/01AB - Blue; box lot 1520-4023, bottle lot 15244006/01AH - White;  b.2) product code 045-088, box lot 53-1593-4006, bottle lots 15224001/01AQ - red, 15203002/01BS - orange, 15144002/01AA - blue and 15124003/01AP - black, and box lot 53-1593-4007, bottle lots 15124003/01AQ - black, 15144002/01AC - blue, 15203002/01BU - orange, 15224001/01AT - red, 15244006/01AF - white, 15263001/01CD - yellow;  c.1) product code 2720, box lot lot 2720-4021, bottle lot 60374001/01AH -pink; box lot 2720-4022, bottle lot 60363002/01BE -yellow; box lot 2720-4023, bottle lot 60374001/01AK - pink;  product code 2793, kit box lot 2793-4005, bottle lots 60343002/02AF - green, 27124001/01AF - orange, 60374001/01AJ - pink, 27164001/01AS - red, 60363002/01BD - yellow and 60353005/01AS - blue;  c.2) product 045-052, box lot 53-2720-4044, bottle lot 60343002/02AE - key lime green
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 45 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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