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U.S. Department of Health and Human Services

Class 2 Device Recall TempSpan CMT Temporary Cement

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  Class 2 Device Recall TempSpan CMT Temporary Cement see related information
Date Initiated by Firm March 03, 2011
Date Posted March 14, 2012
Recall Status1 Terminated 3 on March 14, 2012
Recall Number Z-1205-2012
Recall Event ID 61270
Product Classification Cement, dental - Product Code EMA
Product Brand Name: TempSpan CMT Temporary Cement, a temporary cement.

Part Number: N69CA.

The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.
Code Information Lot Number: 3748413
Recalling Firm/
Manufacturer		 Kerr Corporation
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7400
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 627 units total (601 units in the US)
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada, Philippines, Italy, Netherlands, and the UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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