Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
FDA Recall Z-0035-2008 · Posted 2007-10-02
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Recalling FirmHeraeus Kulzer Inc., Dental Products Division
Recall StatusTerminated
Product CodeKLE
Date Initiated2007-07-09
Date Terminated2008-03-12
Product Quantity1,236
Reason for Recall
The material may solidify in the bottle, and thus be rendered unusable.
Firm Action
Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.
Root Cause
Process design
Distribution Pattern
Nationwide and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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