Recall Z-1522-2014— Integra LifeSciences Corp.

Name: FDA recall Z-1522-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-10

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2014-03-10, terminated 2015-02-13. It names one FDA 510(k) clearance: K981262. Product: Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.. Reason: Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-03-10
Terminated: 2015-02-13
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K981262 — CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMValleylab, Inc.·cleared 1998-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.

Reason for recall

Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.

Data sourced from openFDA. This site is unofficial and independent of the FDA.