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

Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106

FDA Recall Z-0687-06 · Posted 2006-03-28

Recalling FirmKerr Corp
Recall StatusTerminated
Product CodeKLE
Date Initiated2006-03-03
Date Terminated2012-03-07
Product Quantity85

Reason for Recall

The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.

Firm Action

A total of one hundred thirty five (135) consignees were sent the recall communication via USPS 1st class mail and international fax/mail on March 3 and 6, 2006, respectively. There will be an additional thirty seven (37) letters to be sent to consignees in Australia and three (3) letters to be sent to consignees in New Zealand once the Australian Therapeutic Goods Administration approves of a differently formatted letter. 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.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Belgium, Canada, Denmark, Germany, Hungary, Italy, Russia, Spain, United Kingdom, & New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991808OPTIBOND 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.

↑