37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to pre

FDA device recall Z-0156-2012 · posted 2011-11-03 · Terminated

Recall details

Recalling firm

Kerr/pentron Dba Kerr Corporation And Pentron Clinical

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

EBF

Quantity affected

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, F

Date initiated

2011-03-31

Date posted

2011-11-03

Date terminated

2012-08-09

Location

Orange, CA

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