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U.S. Department of Health and Human Services

Class 2 Device Recall Kerr TempBond Clear

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  Class 2 Device Recall Kerr TempBond Clear see related information
Date Initiated by Firm August 14, 2006
Date Posted September 23, 2006
Recall Status1 Terminated 3 on August 03, 2012
Recall Number Z-1524-06
Recall Event ID 36222
510(K)Number K982590  
Product Classification Dental Cement - Product Code EMA
Product TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
Code Information Lot numbers: 444881 and 445348.
Recalling Firm/
Manufacturer		 Kerr Corp
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact Wendy Urtel
949-255-8767
Manufacturer Reason
for Recall		 Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)
FDA Determined
Cause 2		 Other
Action A total of forty-one (41) consignees were sent the recall communication via USPS 1st class mail on August 14, 2006 and thirteen (13) consignees were sent the recall communication via international fax/mail on August 16. Additionally, there will be nine (9) letters sent to consignees in Australia and two (2) letters sent to consignees in New Zealand
Quantity in Commerce 2,007
Distribution Class II Recall - Worldwide distribution ---- including USA and countries Canada, Denmark, France, Germany, Italy, Lithuania, Luxembourg, Mexico, Poland, South Africa, Spain and United Kingdom.
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.
510(K) Database 510(K)s with Product Code = EMA and Original Applicant = SYBRON DENTAL SPECIALTIES, INC.
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