Recall Z-0153-2012
Kerr/pentron Dba Kerr Corporation And Pentron Clinical · initiated March 31, 2011
Product
37% Etching Gel-1ml syringe, part # T06 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.
Codes / lots: all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0153-2012
- Initiated
- March 31, 2011
- Posted by FDA
- November 3, 2011
- Terminated
- August 9, 2012
- Product code
- EBF – Material, Tooth Shade, Resin
- 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, Japan, Kenya, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Poland, Romania, Russia, St.…
- Recalling firm
- Kerr/pentron Dba Kerr Corporation And Pentron Clinical, Orange, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0154-2012 | 37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | 03/31/2011Terminated |
| Z-0155-2012 | 37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | 03/31/2011Terminated |
| Z-0156-2012 | 37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | 03/31/2011Terminated |
| Z-0157-2012 | 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch…Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel… | 03/31/2011Terminated |