Coltene Whaledent Inc: Medical Device Recall in 2020 - (Recall #: Z-0465-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

FG 57 100057X (100057X)

Product Classification:

Class II

Date Initiated: October 20, 2020

Date Posted: November 25, 2020

Recall Number: Z-0465-2021

Event ID: 86694

Reason for Recall:

The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

Status: Ongoing

Product Quantity: 556

Code Information:

J79552

Distribution Pattern:

Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated