Class II — Integra LifeSciences Corp. d.b.a. Integra Pain Management
| 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 | Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile. |
| Product | Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND |
| Quantity | 710 |
| Distribution | Nationwide and VA/govt/military. No foreign consignees. |
| Initiated | 2016-08-24 |
| Classified | 2016-09-02 |
| Terminated | 2017-03-30 |
| Recall number | Z-2733-2016 |
| 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. d.b.a. Integra Pain Management (Z-2733-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75028/
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