Recall Z-0155-2012 ยท EBF Material, Tooth Shade, Resin
Kerr/pentron Dba Kerr Corporation And Pentron Clinical
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.
| Date | Nov 3, 2011 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 41,744 units |
| Distribution | 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, Japa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874189 | DUAL-CURE RADIOPAQUE Pentron Corp., Feb 11, 1988 |