Osteosynthesis Compression Staple EasyClip — Class II medical device recall Z-0457-2021
Ongoing recall by Stryker GmbH, reported 2020-11-25, distributed nationwide. The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who
| Recall number | Z-0457-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, N/A, Switzerland |
| Recall initiated | 2020-09-25 |
| Classified | 2020-11-16 |
| Reported by FDA | 2020-11-25 |
| Distributed | Nationwide (US) |
Product
Osteosynthesis Compression Staple EasyClip
Reason for recall
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.
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-0457-2021. 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.