Date Initiated by Firm |
January 30, 2006 |
Date Posted |
March 09, 2006 |
Recall Status1 |
Terminated 3 on May 04, 2006 |
Recall Number |
Z-0602-06 |
Recall Event ID |
34614 |
Product Classification |
Driver, Wire, And Bone Drill, Manual - Product Code DZJ
|
Product |
Thermoplastic templates, single tooth Catalog Number: 040.526 |
Code Information |
Lot Number: A2283 |
Recalling Firm/ Manufacturer |
Straumann Manufacturing Inc. 60 Minuteman Rd Andover MA 01810-1008
|
For Additional Information Contact |
Bernard McDonald 781-747-2500 Ext. 2514
|
Manufacturer Reason for Recall |
Pilot drills may not fully extend through drill guide in template products
|
FDA Determined Cause 2 |
Other |
Action |
Straumann USA notified consignees by letter dated 1/30/06 requesting return of the devices. |
Quantity in Commerce |
116 |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
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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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