Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1043-04

Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling...

Lang Dental Mfg Co, Inc. / initiated 2004-06-07 / Terminated

Lang Dental Mfg Co, Inc. began a recall of Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram... on . The reason FDA records is "The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1043-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Lang Dental Mfg Co, Inc.
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
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Reason for recall
The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
FDA root cause
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
Product codes and lots
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