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U.S. Department of Health and Human Services

Class 3 Device Recall Correct VPS

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  Class 3 Device Recall Correct VPS see related information
Date Initiated by Firm November 04, 2010
Date Posted March 02, 2012
Recall Status1 Terminated 3 on March 14, 2012
Recall Number Z-1146-2012
Recall Event ID 59959
510(K)Number K914178  
Product Classification Material, impression - Product Code ELW
Product Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.
Code Information Lot Number: 3510059
Recalling Firm/
Manufacturer		 Sybron Dental Specialties
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7480
Manufacturer Reason
for Recall		 Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker.
FDA Determined
Cause 2		 Packaging process control
Action Pentron Clinical sent "Urgent Medical Device Recall" letters dated November 17, 2010 to consignees explaining the above mentioned public reason for recalls and asking them to determine if they have any of the affected products in their in stock. Product that is returned will be replaced at no charge. They also asked that they complete and fax back an enclosed recall return form. Questions can be directed to Customer Service at (800) 551-0283.
Quantity in Commerce 176 units
Distribution Worldwide Distribution, USA including the states of FL, NY, WA, CA, IL, MA, NC, NJ, AZ, FL, KY, CT, PA, IN, NJ, PA, TN, NV, TX and the countries of Canada and Pakistan.
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 = ELW and Original Applicant = JENERIC/PENTRON, INC.
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