Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plasti

FDA device recall Z-1041-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Lang Dental Mfg Co, Inc.

Reason for recall

The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

EBG

Quantity affected

402 units

Distribution

Nationwide

Date initiated

2004-06-07

Date posted

2004-07-20

Date terminated

2004-09-20

Location

Wheeling, IL