Recall Z-2177-2010 ยท NDP Accessories, Implant, Dental, Endosseous
Straumann Manufacturing Inc.
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.
| Date | Aug 6, 2010 (initiated Jun 15, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| 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. |
| Quantity | 163 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.