Class II — Stryker GmbH
| Recalling firm | STRYKER CORP. |
|---|---|
| Registered facility | View this company's 61 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The devices have a different inner diameter than the diameter specified on the outer box label. |
| Product | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S |
| Quantity | 52 |
| Distribution | US Nationwide Distribution |
| Initiated | 2021-05-27 |
| Classified | 2021-07-30 |
| Recall number | Z-2170-2021 |
| 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 — Stryker GmbH (Z-2170-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88240/
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