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U.S. Department of Health and Human Services

Class 3 Device Recall 37 Etching Gel3ml syringe

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 Class 3 Device Recall 37 Etching Gel3ml syringesee related information
Date Initiated by FirmMarch 31, 2011
Date PostedNovember 03, 2011
Recall Status1 Terminated 3 on August 09, 2012
Recall NumberZ-0156-2012
Recall Event ID 60114
510(K)NumberK874189 
Product Classification Material, tooth shade, resin - Product Code EBF
Product37% Etching Gel-3ml syringe, part #N01H 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.
Code Information all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007
Recalling Firm/
Manufacturer		 Kerr/pentron Dba Kerr Corporation And Pentron Clinical
1717 W. Collins Ave
Orange CA 92867
For Additional Information Contact
714-516-7400
Manufacturer 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 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce41,744 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EBF
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