Device Recall Breeze SelfAdhesive Resin Cement 의 리콜

Recall

60242

Class 2

Z-0186-2012

2011-07-08

2011-11-14

Terminated

United States

2013-06-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104859

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.

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.