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Terminated

Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088

FDA Recall Z-1035-04 · Posted 2004-07-20

Recalling FirmThe Straumann Company
Recall StatusTerminated
Product CodeDZE
Date Initiated2004-05-21
Date Terminated2004-11-16
Product Quantity23 units

Reason for Recall

Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN)

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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