PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental composite

FDA device recall Z-0265-2009 · posted 2008-11-25 · Terminated

Recall details

Recalling firm

Kerr Corp

Reason for recall

Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.

Action taken

Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit. The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attached Recall Return Form to 714-516-7739. If the customers were an authorized Kerr distributor, they were requested to identify and recover the affected product lots listed on the attached Lot Number Table that may have been shipped to their customers. Also, customers were instructed to contact Kerr Customer Care at 1 -800-537-7123 directly to handle the arrangements of a quick return and replacement

Root cause

Component design/selection

Status

Terminated

Product code

EBF

Quantity affected

22,478 packs for all affected lots

Distribution

Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.

Date initiated

2008-09-05

Date posted

2008-11-25

Date terminated

2012-03-07

Location

Orange, CA

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