Integra CUSA Excel Disposable Wrench — Class II medical device recall Z-1522-2014
Terminated recall by Integra LifeSciences Corp., reported 2014-05-07, distributed nationwide. Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the
| Recall number | Z-1522-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2014-03-10 |
| Classified | 2014-04-29 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH |
| Lot numbers | 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873, 1135014 |
| Model numbers | C5601 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1522-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.