Coltene Whaledent recalls CEI Cutting Edge PTC-57C dental instruments due to incorrect packaging causing excessive material removal. Affected units may cause damage to dental work.
“Colt: CEI Cutting Edge Instruments PTC-57C Recall - Incorrect Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64070-colt-cei-cutting-edge-instruments-ptc-57c-recall-incorrect-packaging. Based on FDA recall #Z-0467-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0467-2021%22&limit=1).
Coltene Whaledent Inc recalled CEI Cutting Edge Instruments (PTC-57C) due to incorrect packaging of FG 557 burs as FG 57 burs, which may remove excessive material. The Food and Drug Administration announced the voluntary Class II recall on Oct. 20, 2020.
How to tell if you have it
Brand: Coltene Whaledent
Product: CEI Cutting Edge Instruments (PTC-57C)
Lot code: J88954
Units affected: 556
The hazard
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.
Context
GovInfoNow's records show Coltene Whaledent Inc has issued five other recalls since April 13, 2018. Recent brand recalls include a Jan. 20, 2023 recall of STATIS SL S10001 Dental Handpieces for loose parts risk and a March 18, 2021 recall of dental pins for incorrect packaging. Other recent recalls of similar products include Henry Schein's July 9, 2026 Structur 2 SC Resin Cartridge Refills with Incorrect Packaging, Straumann's July 13, 2026 GM Helix Dental Implant Recall for packaging mismatch risk, and Stryker's June 8, 2026 AHTO Tube Set Packaging Recall.
How to tell if you have this one
Check for CEI Cutting Edge Instruments (PTC-57C) with model number J88954. The FG 557 burs were incorrectly labeled as FG 57 burs in the packaging.
Brand
Coltene Whaledent
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
Verify the model number on the instrument packaging or label to confirm it is not J88954.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0467-2021 (October 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0467-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.