Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088
FDA device recall Z-1035-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- The Straumann Company
- Reason for recall
- Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN)
- Action taken
- 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
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 23 units
- Distribution
- Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX
- Date initiated
- 2004-05-21
- Date posted
- 2004-07-20
- Date terminated
- 2004-11-16
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.