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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJanuary 30, 2006
Date PostedMarch 09, 2006
Recall Status1 Terminated 3 on May 04, 2006
Recall NumberZ-0603-06
Recall Event ID 34614
Product Classification Driver, Wire, And Bone Drill, Manual - Product Code DZJ
ProductThermoplastic templates, free-end situation Catalog Number: 040.527
Code Information Lot Number: A2284
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann Manufacturing Inc.
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactBernard 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
ActionStraumann USA notified consignees by letter dated 1/30/06 requesting return of the devices.
Quantity in Commerce22
DistributionNationwide
Total Product Life CycleTPLC 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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