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

FDA device recall Z-1883-2018 · posted 2018-05-14 · Terminated

Recall details

Recalling firm

Coltene Whaledent Inc

Reason for recall

The products are labeled with an incorrect product number.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

EJL

Quantity affected

11

Distribution

The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada

Date initiated

2018-04-13

Date posted

2018-05-14

Date terminated

2019-04-08

Location

Cuyahoga Falls, OH