Coltene Whaledent Inc CEI Cutting Edge Instruments (PTC-57C) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CEI Cutting Edge Instruments (PTC-57C)
Brand
Coltene Whaledent Inc
Lot Codes / Batch Numbers
J88954
Products Sold
J88954
Coltene Whaledent Inc is recalling CEI Cutting Edge Instruments (PTC-57C) due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On October 20, 2020, the firm emailed Urgent Medical Device Recall letters to affected distributors. Customers were informed that the incorrect dental carbide bur was manufactured and subsequently packaged and distributed. Customers were asked to return the product to Coltene/Whaledent, Inc. by following the instructions in the letter. The firm will replace the product at no cost. Please inform the firm if you have already used the product. Distributors were asked to either identify and notify their customers who were shipped the affected product or to provide a list of affected customers to the recalling firm so that Coltene/Whaledent, Inc. could notify them.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IN, NV, PA, TN, TX
Page updated: Jan 10, 2026