Recall Z-0464-2021
Coltene Whaledent Inc · initiated October 20, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Alpen Clinic 100 Carbide Instruments (R100057C)
Codes / lots: J75023
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0464-2021
- Initiated
- October 20, 2020
- Product code
- EJL – Bur, Dental
- Quantity
- 556 packs
- Distribution
- Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
- Recalling firm
- Coltene Whaledent Inc, Cuyahoga Falls, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0465-2021 Class II | FG 57 100057X (100057X)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |
| Z-0466-2021 Class II | Clinic Pack 100 Pieces FG 57 100057C (100057C)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |
| Z-0467-2021 Class II | CEI Cutting Edge Instruments (PTC-57C)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |
| Z-0468-2021 Class II | Strauss 25 Carbide Dental Burs (100057XXV)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |