Device recall

Z-1522-2014: Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+…

FDA device recall · Class II · Integra LifeSciences Corp.

Key facts

Recall number (Z-number) Z-1522-2014
Recall event 67902
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.
Product code LFL
Recalling firm Integra LifeSciences Corp.
Recall class Class II
Status Terminated
Termination date Feb 13, 2015
510(k) numbers K981262
FEI number 3003418325

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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