Device product

SwishPlus Implant Intended for use in support for fixed bridgework.

Z-1168-2018

January 19, 2018

Class II

Product summary

Firm: Implant Direct Sybron Manufacturing, LLC
Event: Event 79396
Status: Terminated
Classification: Class II
Quantity: 1,117 units total
Official record key: device-enforcement:Z-1168-2018

Official wording

Reason: 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).

Code information: Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).

Distribution pattern: Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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).