Terminated

37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.

FDA Recall Z-0155-2012 · Posted 2011-11-03

Recalling FirmKerr/pentron Dba Kerr Corporation And Pentron Clinical

Recall StatusTerminated

Product CodeEBF

Date Initiated2011-03-31

Date Terminated2012-08-09

Product Quantity41,744 units

Reason for Recall

Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.

Firm Action

The firm, Pentron Clinical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 31, 2011, with attached Return Form (via USPS 1st class mail) to all their consignees/customers. The letter describes the product, problem and action to be taken. All consignees/customers were instructed to complete the Recall Return Form via fax to: 1-877-677-8844 and to return any affected product in their inventory. Affected products will have expiration dates between April 2011 and April 2015. Consignees/customers with questions can contact Pentron Clinical Customer Service at (800) 551-0283 directly to handle the arrangements of a quick return and replacement.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution: USA (nationwide) and countries of: Armenia, Austria, Australia, Antigua & Barbuda, Barbados, Belarus, Bulgaria, Canada, Czech Republic, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Poland, Romania, Russia, St. Vincent & Grenadine, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, Ukraine, UK, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K874189DUAL-CURE RADIOPAQUEPentron Corp. · 1988-02-11

Official Source

View FDA Recall →

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