Integra LifeSciences Corp.: Medical Device Recall in 2019 - (Recall #: Z-0613-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Product Classification:

Class II

Date Initiated: October 21, 2019

Date Posted: December 18, 2019

Recall Number: Z-0613-2020

Event ID: 84216

Reason for Recall:

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Status: Terminated

Product Quantity: 820

Code Information:

US Ops Manual P/N 60905769

Distribution Pattern:

US: AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS NC NE NJ NY OH OK OR PA SC TN UT VA WA WI WV International: SG MX CA JP AU CO TH HK

Voluntary or Mandated:

Voluntary: Firm initiated