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 device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used. |
| Product | Osteosynthesis Compression Staple EasyClip |
| Quantity | 121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US. |
| Distribution | The devices were distributed nationwide throughout the US, and to countries OUS. Easy Clip devices: As of 09/04/2020, 251,566 EasyClip devices have been manufactured. 121,517 of those devices were distributed to the US, and 102,529 were distributed in countries OUS. 27,520 devices were left in the firm's inventory. Easy Clip Xpress devices: As of 09/04/2020, 37,371 EasyClip Xpress devices … |
| Initiated | 2020-09-25 |
| Classified | 2020-11-16 |
| Recall number | Z-0457-2021 |
| 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-0457-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86597/
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