Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to

FDA device recall Z-1205-2012 · posted 2012-03-14 · Terminated

Recall details

Recalling firm

Kerr Corporation

Reason for recall

The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste, and it may set faster than specified.

Action taken

Pentron Clinical sent an Urgent Medical Device Recall letter dated April 20, 2011, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax back the enclosed recall form to 1-877-677-8844 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. For questions regarding this recall call 714-516-7400.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

EMA

Quantity affected

627 units total (601 units in the US)

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Canada, Philippines, Italy, Netherlands, and the UK.

Date initiated

2011-03-03

Date posted

2012-03-14

Date terminated

2012-03-14

Location

Orange, CA