CLASS II ONGOING Device recall · Reported 25 Nov 2020 · FDA Enforcement Report
Alpen Clinic 100 Carbide Instruments (R100057C) recalled
Coltene Whaledent is recalling Alpen Clinic 100 Carbide Instruments (R100057C), distributed in Florida, Nevada, Pennsylvania, Tennessee, Texas. The recall was initiated on 20 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0464-2021
- FDA event ID
- 86694
- Recalling firm
- Coltene Whaledent, Cuyahoga Falls, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Oct 2020
- FDA classified
- 17 Nov 2020
- Reported
- 25 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 20 Oct 2020 | Recall initiated by company | |
| 17 Nov 2020 | Classified by FDA | +28 days |
| 25 Nov 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Alpen Clinic 100 Carbide Instruments (R100057C)
Where it was distributed
Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
J75023
Where was it sold?
Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 86694This product is part of a recall event; the main page for the event is CEI Cutting Edge Instruments (PTC-57C) recalled by Coltene Whaledent.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CEI Cutting Edge Instruments (PTC-57C) recalled by Coltene Whaledent | Coltene Whaledent | Packaging Defects | 5 states | |
| CLASS II | Fg 57 100057x (100057x) recalled by Coltene Whaledent | Coltene Whaledent | Packaging Defects | 5 states | |
| CLASS II | Clinic Pack FG 57 100057C (100057C) recalled by Coltene Whaledent | Coltene Whaledent | Packaging Defects | 5 states | |
| CLASS II | Strauss 25 Carbide Dental Burs (100057XXV) recalled by Coltene Whaledent | Coltene Whaledent | Packaging Defects | 5 states |
More recalls from Coltene Whaledent
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SciCan Statis SL S10001 Dental Handpieces-Intended recalled | Coltene Whaledent | Other | Nationwide |
| Device | CLASS II | Dental pins - Tms Link Plus Self-Threading Pins recalled | Coltene Whaledent | Packaging Defects | Nationwide |
| Device | CLASS II | Strauss 25 Carbide Dental Burs (100057XXV) recalled by Coltene Whaledent | Coltene Whaledent | Packaging Defects | 5 states |
| Device | CLASS II | Clinic Pack FG 57 100057C (100057C) recalled by Coltene Whaledent | Coltene Whaledent | Packaging Defects | 5 states |
| Device | CLASS II | Fg 57 100057x (100057x) recalled by Coltene Whaledent | Coltene Whaledent | Packaging Defects | 5 states |
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|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |