Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084
FDA device recall Z-0300-05 · posted 2004-12-09 · Terminated
Recall details
- Recalling firm
- The Straumann Company
- Reason for recall
- Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN)
- Action taken
- Straumann USA notified users by letter dated 11/11/04 via overnight mail advising users of the label error.
- Root cause
- Other
- Status
- Terminated
- Product code
- NDP
- Quantity affected
- 85 units
- Distribution
- Nationwide
- Date initiated
- 2004-11-11
- Date posted
- 2004-12-09
- Date terminated
- 2005-02-17
- Location
- Waltham, MA
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