Z-1883-2018Class II

Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device...

Name: Z-1883-2018 Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device...
Creator: Coltene Whaledent Inc
Published: 2018-04-13
License: https://open.fda.gov/license/

Coltene /Whaledent AG / initiated 2018-04-13 / Terminated / root cause: labeling and UDI

FDA source

Coltene Whaledent Inc began a recall of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide... on 2018-04-13. FDA classified it as Class II and gives the reason as "The products are labeled with an incorrect product number". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1883-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-13
Posted: 2018-05-14
Terminated: 2019-04-08
Recalling firm: Coltene /Whaledent AG
Product: Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Product code: EJL Bur, Dental
Reason for recall: The products are labeled with an incorrect product number.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Customers were contacted via telephone call on 4/13/18. The customers were asked the following questions: 1. Confirm that {name of Distributor} received {number of packs} around this date {date}. 2. Confirm that the affected product, lot number I37460, is still in their inventory. a. If not, to whom was it shipped to? [Coltene will need that contact information]. 3. Can you take a picture of the lot number I37460 that you received and send to {Regional sales manager}? 4. Please return the product in question to Coltene per Vendor Return Authorization with full tracking information.
Quantity in commerce: 11
Distribution: The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Product codes and lots: Batch I37640

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1883-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1883-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15

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)