Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this

FDA device recall Z-0454-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Kerr/pentron Dba Kerr Corporation And Pentron Clinical

Reason for recall

The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications.

Action taken

The firm, Pentron Clinical, sent an " URGENT: MEDICAL DEVICE RECALL" letters dated April 4, 2011 and April 20, 2011 via USPS 1st class mail to its customers. The letter describes the product, problem and actions to be taken. The letter instructed customers to review the table with affected product lots and determine if the affected products was in their inventory; return the affected product for a replacement at no charge; contact Pentron Clinical Customer Service at (800) 551-0283; 1-800-243-3969 ext. 677 or email: aestridge@pentron.com directly to handle the arrangements of a quick return and replacement; and complete and fax back the enclosed Recall Return Form at 1-877-677-8844. The letter also request the customer to identify and recover the affected product lots that may have been shipped to thier customers. If you have any questions, contact Pentron Clinical Customer Service at (800) 551-0283.

Root cause

Other

Status

Terminated

Product code

EMA

Quantity affected

157

Distribution

Worldwide distribution: USA (nationwide) including states of: PA, IL, NV, WA, OH, TN, WI, NY, NJ, CT, IN FL, MI, OK, NE, HI, VA, CA, and TX; and countries of : Canada, Egypt, Isreal, Netherlands, Swed

Date initiated

2011-03-17

Date posted

2012-01-11

Date terminated

2014-01-22

Location

Orange, CA

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