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U.S. Department of Health and Human Services

Class 3 Device Recall Straumann TSleeve

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  Class 3 Device Recall Straumann TSleeve see related information
Date Initiated by Firm June 04, 2009
Date Posted November 04, 2010
Recall Status1 Terminated 3 on February 20, 2012
Recall Number Z-0320-2011
Recall Event ID 52231
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Straumann T-Sleeve 2.8mm, height 6mm, guided
Article Number: 034.055V46
Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site.
Code Information Lot# R9483
Recalling Firm/
Manufacturer		 Straumann Manufacturing Inc.
60 Minuteman Rd
Andover MA 01810
For Additional Information Contact
800-448-8168
Manufacturer Reason
for Recall		 Incorrect Inner diameter of the T-sleeve
FDA Determined
Cause 2		 Process control
Action Strauman USA LLC notified the consignee by telephone on June 4, 2009, and sent an Urgent Device Recall letter dated, June 8, 2009 as a follow-up. The letter described the product, the problem, and the action to be taken by the customer. The customer was asked to return any affected product, in the prepaid preprinted mailer pouch as soon as possible to: T-sleeve Recall, Straumann USA, LLC 60 Minuteman Road Andover, MA, 01810 Customers were asked to sign and indicate on the Recall Acknowledgement Form if they would like a replacement product or a credit to their account for the product returned and fax the form to (978) 747-0023. For any questions regarding this recall call (978) 747-2575.
Quantity in Commerce 3 units
Distribution Worldwide Distribution - Canada
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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