FDA Device recall Z-0457-2021
Osteosynthesis Compression Staple EasyClip
- FDA Device
- Class II
- ongoing
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of Osteosynthesis Compression Staple EasyClip by Stryker, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0457-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-25 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker |
| Distribution | US |
Product
Osteosynthesis Compression Staple EasyClip
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.
Identifiers
| code_info | All lots of the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress are affected. Exp. Date: 5 years from d…All lots of the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress are affected. Exp. Date: 5 years from date of manufacturing EasyClip and EasyClip Xpress staples are available in a variety of sizes identified by product and catalog numbers. See below: Product Number Product Description EZ15-12-12 Osteosynthesis Compression Staple EasyClip 15x12x12mm EZ15-15-15 Osteosynthesis Compression Staple EasyClip 15x15x15mm EZ18-12-12 Osteosynthesis Compression Staple EasyClip 18x12x12mm EZ18-15-13 Osteosynthesis Compression Staple EasyClip 18x15x13mm EZ18-14-14 Osteosynthesis Compression Staple EasyClip 18x14x14mm EZ18-17-15 Osteosynthesis Compression Staple EasyClip 18x17x15mm EZ18-19-17 Osteosynthesis Compression Staple EasyClip 18x19x17mm EZ20-16-16 Osteosynthesis Compression Staple EasyClip 20x16x16mm EZ20-20-20 Osteosynthesis Compression Staple EasyClip 20x20x20mm EZ25-22-22 Osteosynthesis Compression Staple EasyClip 25x22x22mm E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0457-2021%22
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