Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2018 - (Recall #: Z-1168-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

SwishPlus Implant Intended for use in support for fixed bridgework.

Product Classification:

Class II

Date Initiated: January 19, 2018

Date Posted: March 28, 2018

Recall Number: Z-1168-2018

Event ID: 79396

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).

Status: Terminated

Product Quantity: 1,117 units total

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.

Voluntary or Mandated:

Voluntary: Firm initiated