Class II — Integra LifeSciences Corp.
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 3,984 devices packaged as 6 devices / box (664 boxes) |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland. |
| Initiated | 2014-03-10 |
| Classified | 2014-04-29 |
| Terminated | 2015-02-13 |
| Recall number | Z-1522-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-1522-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67902/
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