Food, drugs, devices › Coltene Whaledent Inc
Device recall: Alpen Clinic 100 Carbide Instruments (R100057C)
Coltene Whaledent Inc (Cuyahoga Falls, OH) initiated this device recall on 20 Oct 2020; FDA lists 5 product records under event 86694, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Coltene Whaledent Inc has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Coltene Whaledent Inc, Cuyahoga Falls, OH.
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."
Distribution
"Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0464-2021 | Alpen Clinic 100 Carbide Instruments (R100057C) | 556 packs | Class II | Ongoing | 25 Nov 2020 |
| Z-0465-2021 | FG 57 100057X (100057X) | 556 | Class II | Ongoing | 25 Nov 2020 |
| Z-0466-2021 | Clinic Pack 100 Pieces FG 57 100057C (100057C) | 556 | Class II | Ongoing | 25 Nov 2020 |
| Z-0467-2021 | CEI Cutting Edge Instruments (PTC-57C) | 556 | Class II | Ongoing | 25 Nov 2020 |
| Z-0468-2021 | Strauss 25 Carbide Dental Burs (100057XXV) | 556 | Class II | Ongoing | 25 Nov 2020 |
Context
Other enforcement events for Coltene Whaledent Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Jan 2023 | SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, c | Device | Class II | 1 |
| 18 Mar 2021 | Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental rest | Device | Class II | 1 |
| 3 Jun 2020 | HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunct | Device | Class II | 4 |
| 21 Aug 2018 | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into | Device | Class II | 1 |
| 13 Apr 2018 | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from c | Device | Class II | 1 |
| 11 Dec 2013 | Latex Dental Dams labeled as Non-Latex Dental Dams | Device | Class II | 1 |
All 7 events for Coltene Whaledent Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.