Home / Recalls / Coltene Whaledent Inc / Z-0467-2021

Z-0467-2021 Class II Ongoing

Recalled by Coltene Whaledent Inc — Cuyahoga Falls, OH

Recall Details

Product Type
Devices
Report Date
November 25, 2020
Initiation Date
October 20, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
556

Product Description

CEI Cutting Edge Instruments (PTC-57C)

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.

Distribution Pattern

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

Code Information

J88954

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  • Z-0468-2021 Class II — Strauss 25 Carbide Dental Burs (100057XXV) (October 20, 2020)
  • Z-0464-2021 Class II — Alpen Clinic 100 Carbide Instruments (R100057C) (October 20, 2020)
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