CLASS II ONGOING Device recall · Reported 25 Nov 2020 · FDA Enforcement Report
CEI Cutting Edge Instruments (PTC-57C) recalled by Coltene Whaledent
Coltene Whaledent is recalling CEI Cutting Edge Instruments (PTC-57C), 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-0467-2021
- 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
CEI Cutting Edge Instruments (PTC-57C)
Where it was distributed
Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Questions about this recall
Is CEI Cutting Edge Instruments (PTC-57C) recalled?
Yes. Coltene Whaledent recalled CEI Cutting Edge Instruments (PTC-57C) on 20 Oct 2020. The recall is Class II and its status is Ongoing. Recall number Z-0467-2021.
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?
J88954
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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