CEI Cutting Edge Instruments (PTC-57C)
Reported: November 25, 2020 Initiated: October 20, 2020 #Z-0467-2021
Product Description
CEI Cutting Edge Instruments (PTC-57C)
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.
Details
- Recalling Firm
- Coltene Whaledent Inc
- Units Affected
- 556
- Distribution
- Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
- Location
- Cuyahoga Falls, OH
Frequently Asked Questions
What product was recalled? ▼
CEI Cutting Edge Instruments (PTC-57C). Recalled by Coltene Whaledent Inc. Units affected: 556.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0467-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11