Stryker recalls Osteosynthesis Compression Staple EasyClip products for potential nickel release in children under 20 kg when 2+ implants are used. Affected models include EasyClip and EasyClip Xpress sizes up to 25x22x22mm.
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.
Stryker is recalling Osteosynthesis Compression Staple EasyClip and EasyClip Xpress products due to a risk of nickel release in children weighing less than 20 kg when two or more implants are used. This could cause health issues if the nickel levels exceed safe limits.
The device may release nickel above safe levels in children under 20 kg when two or more implants are used. Nickel is a known allergen that can cause allergic reactions or other health issues in sensitive individuals.
Children under 20 kg (44 lbs) who have received two or more EasyClip or EasyClip Xpress implants. Parents and caregivers of pediatric patients are most at risk.
Check for EasyClip or EasyClip Xpress products with product numbers listed in the recall notice, such as EZ15-12-12 (15x12x12mm) or EZBXP10-15-13 (EasyClip Xpress 10x15x13mm). All models were manufactured with a 5-year expiration date from production.
Look for product numbers like EZ15-12-12 or EZBXP10-15-13 on the device packaging or label.
Reach out to Stryker directly for assistance with the recall process or to confirm if your device is affected.
The device has the potential to release nickel above safe levels in children under 20 kg when two or more implants are used.
All EasyClip and EasyClip Xpress products with product numbers listed in the recall notice, including sizes from 8x8x8mm to 25x22x22mm.
Check the product number on your device, such as EZ15-12-12 for 15x12x12mm EasyClip or EZBXP10-15-13 for EasyClip Xpress 10x15x13mm.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0457-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0457-2021 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
