Z-0464-2021Class II

Alpen Clinic 100 Carbide Instruments (R100057C)

Name: Z-0464-2021 Alpen Clinic 100 Carbide Instruments (R100057C)
Creator: Coltene Whaledent Inc
Published: 2020-10-20
License: https://open.fda.gov/license/

Coltene /Whaledent AG / initiated 2020-10-20 / Open, Classified / root cause: packaging

FDA source

Coltene Whaledent Inc began a recall of Alpen Clinic 100 Carbide Instruments (R100057C) on 2020-10-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0464-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-10-20
Posted: 2020-11-17
Recalling firm: Coltene /Whaledent AG
Product: Alpen Clinic 100 Carbide Instruments (R100057C)
Product code: EJL Bur, Dental
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On October 20, 2020, the firm emailed Urgent Medical Device Recall letters to affected distributors. Customers were informed that the incorrect dental carbide bur was manufactured and subsequently packaged and distributed. Customers were asked to return the product to Coltene/Whaledent, Inc. by following the instructions in the letter. The firm will replace the product at no cost. Please inform the firm if you have already used the product. Distributors were asked to either identify and notify their customers who were shipped the affected product or to provide a list of affected customers to the recalling firm so that Coltene/Whaledent, Inc. could notify them.
Quantity in commerce: 556 packs
Distribution: Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Product codes and lots: J75023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0464-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-17
Z-0465-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-17
Z-0466-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-17
Z-0467-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-17
Z-0468-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-17

Product code EJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)