Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation

FDA device recall Z-0186-2012 · posted 2011-11-14 · Terminated

Recall details

Recalling firm

Kerr/pentron Dba Kerr Corporation And Pentron Clinical

Reason for recall

Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.

Action taken

Pentron Clinical sent an "Urgent: Medical Device Recall" letter dated July 18, 2011 with an attached Recall Return Form (via USPS First Clas mail) to all affected customers. The letter identified the affected product, explanation of the problem, and actions to be taken. Customers were instructed to discontinue use and return any affected product in their inventory. The letter asks that each customer complete and return the enclosed Recall Return Form via fax to 714-288-4609, in order to confirm receipt of the customer notification. Customers were instructed to contact Pentron Clinical Customer service at (800) 551-0283 (option 1) directly to handle the arrangements of a quick return and replacement.

Root cause

Pending

Status

Terminated

Product code

EMA

Quantity affected

336 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.

Date initiated

2011-07-08

Date posted

2011-11-14

Date terminated

2013-06-28

Location

Orange, CA

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