Home / Recalls / Coltene Whaledent Inc / Z-0464-2021

Z-0464-2021 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 packs

Product Description

Alpen Clinic 100 Carbide Instruments (R100057C)

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

J75023

Other recalls by Coltene Whaledent Inc

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  • Z-0466-2021 Class II — Clinic Pack 100 Pieces FG 57 100057C (100057C) (October 20, 2020)
  • Z-0468-2021 Class II — Strauss 25 Carbide Dental Burs (100057XXV) (October 20, 2020)
  • Z-0467-2021 Class II — CEI Cutting Edge Instruments (PTC-57C) (October 20, 2020)
  • Z-0465-2021 Class II — FG 57 100057X (100057X) (October 20, 2020)
  • Z-2420-2020 Class II — HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam force (June 3, 2020)
  • Z-2419-2020 Class II — HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam for (June 3, 2020)
  • Z-2422-2020 Class II — HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam fo (June 3, 2020)
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