Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.
FDA Recall Z-2177-2010 · Posted 2010-08-06
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Recalling FirmStraumann Manufacturing Inc.
Recall StatusTerminated
Product CodeNDP
Date Initiated2010-06-15
Date Terminated2011-09-22
Product Quantity163
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.
Firm Action
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
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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