SwishPlus Implant Intended for use in support for fixed bridgework.
FDA Recall Z-1168-2018 · Posted None
Advertisement
Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2018-01-19
Date Terminated2023-07-26
Product Quantity1,117 units total
Reason for Recall
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Firm Action
Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement