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U.S. Department of Health and Human Services

Class 3 Device Recall Straumann

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  Class 3 Device Recall Straumann see related information
Date Initiated by Firm May 21, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 16, 2004
Recall Number Z-1035-04
Recall Event ID 29271
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel
Article No. 044.088
Code Information Lot: 1215
Recalling Firm/
Manufacturer		 The Straumann Company
1601 Trapelo Rd
Waltham MA 02451-7333
For Additional Information Contact Linda Jalbert
781-890-0001 Ext. 9806
Manufacturer Reason
for Recall		 Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN)
FDA Determined
Cause 2		 Other
Action Straumann notifed conisignees by letter on May 21,2004 via Fed''X overnight advising of the error on the label states WN instead of RN. The user is advised to that the ID on the article is incorrect.
Quantity in Commerce 23 units
Distribution Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX
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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