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FDA Medical Device Recalls (openFDA)

Harry J Bosworth Company: Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two - 6 oz. bottles of TruRepair Powder; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 092160

Recall number
Z-0419-05
Recalling firm
Harry J Bosworth Company
Product
Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two - 6 oz. bottles of TruRepair Powder; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 092160
Status
Terminated
Initiated
2004-09-23
Posted
2005-01-25
Terminated
2006-04-24
Reason
The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If teh Trusoft liquid is used the repair material will not set up.
Root cause
Other
Action
Customers were notified by telephone calls on 9/23/04. The accounts were informed of the mix-up with the liquids and were requested to return the kits for replacement.
Quantity
38 kits
Distribution
New York, Washington, New Jersey, Arizona, Minnesota, Wisconsin,Oregon and California.
Lot, serial or model codes
lot number 0404-220, exp. 2007-04
510(k) numbers
not on file
PMA numbers
not on file
Product code
EDI
Firm FEI
1410638
Firm city
Skokie
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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