CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

Recall Insight

This FDA Devices action (record #Z-0135-2017) was formally reported on October 26, 2016, with the manufacturer initiating the action on June 27, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. ConMed Corporation is listed as the recalling firm, operating out of Utica, NY. Federal records indicate N/A units are affected.

The documented reason for this recall is: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.