Integra LifeSciences Corp.: Medical Device Recall in 2019 - (Recall #: Z-0646-2020)

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-0646-2020

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 Operators 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: N/A

Code Information:

Korean OPS Manual P/N 60905212

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