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Class 3 Device Recall Straumann |
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Date Initiated by Firm |
March 30, 2006 |
Date Posted |
May 04, 2006 |
Recall Status1 |
Terminated 3 on June 14, 2006 |
Recall Number |
Z-0840-06 |
Recall Event ID |
35220 |
510(K)Number |
K960634
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Product Classification |
Implant, Endosseous, Root-Form - Product Code DZE
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Product |
Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043 |
Code Information |
Lot Number: A3667 |
Recalling Firm/ Manufacturer |
Straumann Manufacturing Inc. 60 Minuteman Rd Andover MA 01810-1008
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For Additional Information Contact |
Bernard M.McDonald 978-747-2514
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Manufacturer Reason for Recall |
The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top
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FDA Determined Cause 2 |
Other |
Action |
Straumann USA notified accounts by letter dated 3/30/06 via Federal Express. Accounts are requested to return stock. |
Quantity in Commerce |
103 units |
Distribution |
Nationwide. CA, CO, CT, IA, IL, IN, FL, GA, MA , MD, MS, NC, NY, OH, OK, PA, TX, WA |
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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510(K) Database |
510(K)s with Product Code = DZE and Original Applicant = THE STRAUMANN CO.
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