| | Class 3 Device Recall Straumann |  |
| Date Initiated by Firm | May 21, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on November 16, 2004 |
| Recall Number | Z-1035-04 |
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| 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 |
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| 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 |
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Manufacturer Reason
for Recall | Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN) |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 23 units |
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| Distribution | Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX |
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| 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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