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Terminated

Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.

FDA Recall Z-2128-2014 · Posted 2014-07-29

Recalling FirmNovocol, Inc.
Recall StatusTerminated
Product CodeKLE
Date Initiated2014-07-16
Date Terminated2014-12-31
Product Quantity60

Reason for Recall

Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

Firm Action

An email was sent on 7/16/14 to the two distributors requesting the return of all units of Lot C4211-3 in stock.

Root Cause

Process design

Distribution Pattern

Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042614S&C-SELF ETCH PR-BONDS & C Polymer GmbH · 2004-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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