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 | Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier |
| Product | CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037 |
| Quantity | 906 units |
| Distribution | US Nationwide Distribution - Foreign Distribution: Hong Kong |
| Initiated | 2021-06-01 |
| Classified | 2021-08-06 |
| Terminated | 2023-01-27 |
| Recall number | Z-2224-2021 |
| 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-2224-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88312/
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