Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Straumann Handpiece Driver

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Straumann Handpiece Driver see related information
Date Initiated by Firm May 28, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on November 06, 2009
Recall Number Z-1876-2008
Recall Event ID 48610
Product Classification Endosseous dental implant - Product Code DZE
Product Straumann Handpiece Driver for RN Solid Abutment 6¿ L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.
Code Information Lot Number: C4724
Recalling Firm/
Manufacturer		 Straumann Manufacturing Inc.
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact
800-448-8168
Manufacturer Reason
for Recall		 Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On May 28, 2008, Straumann issued an Urgent Device Recall and a Recall Acknowledgement Form to its consignees via Fed Ex. Accounts are requested to return product and a replacement or credit will issue. If you have any questions contact Bernie McDonald at (978) 747-2514.
Quantity in Commerce 129 units
Distribution Class III Recall - Nationwide Distribution.
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.
-
-