Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966

FDA Recall Z-1521-06 · Posted 2006-09-23

Recalling FirmKerr Corp
Recall StatusTerminated
Product CodeKLE
Date Initiated2006-08-29
Date Terminated2012-08-03
Product Quantity247 Kits (50 unidose pouches/Kit)

Reason for Recall

Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.

Firm Action

A total of thirty-four (34) consignees were sent the recall communication via USPS 1st class mail on August 29, 2006. There will be an additional five (5) letters that will be sent to consignees in Europe once the recall communication is translated into their respective languages. The consignees were instructed to complete the Return Form and return any affected product in their inventory. They were also requested to recover any affected product that they may have shipped to their customers. Periodic effectiveness checks will be conducted in order to follow up with non-responders.

Root Cause

Other

Distribution Pattern

World wide; USA and countries of Australia, Belgium, Canada, China, France, Sweden and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014027OPTIBOND SOLO PLUS 4Kerr Dental Materials Center · 2002-02-22K991808OPTIBOND SOLO PLUS 2Sybron Dental Specialties, Inc. · 1999-07-09

Official Source

View FDA Recall →

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

↑