Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrica
FDA device recall Z-2177-2010 · posted 2010-08-06 · Terminated
Recall details
- Recalling firm
- Straumann Manufacturing Inc.
- Reason for recall
- The label on the tubular packaging for the Straumann Impression set f. WN solid abutment has the incorrect description of RN solid abutment instead of a WN.
- Action taken
- Field Safety Notice, dated June 15, 2010, issued to consignees states that the 040.380 Impression set f. WN solid abutment Lot Y4021 which you purchased is incorrectly labeled Impression set f. RN solid abutment. Customers were asked to return the affected products and completed Customer Confirmation Form for replacements. Questions should be directed towards Bernard McDonald at 978-747-2514.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- NDP
- Quantity affected
- 163
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-06-15
- Date posted
- 2010-08-06
- Date terminated
- 2011-09-22
- Location
- Andover, MA
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