Lower riskMedical device recall · FDA · Published September 25, 2020
Stryker Osteosynthesis Compression Staple EasyClip Recall: Nickel Risk in Pediatric
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 Osteosynthesis Compression Staple EasyClip Recall: Nickel Risk in Pediatric.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64143-stryker-osteosynthesis-compression-staple-easyclip-recall-nickel-risk-in-pediatric. Based on FDA recall #Z-0457-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0457-2021%22&limit=1).
The FDA announced on 2020-09-25 that Stryker GmbH is recalling Osteosynthesis Compression Staple EasyClip devices due to potential nickel release above safety margins in pediatric patients weighing less than 44.09 lbs when two or more implants are used, according to the FDA.
How to tell if you have it
Brand: Stryker
Product: Osteosynthesis Compression Staple EasyClip and EasyClip Xpress
Distribution: Nationwide in the US and to countries OUS as of 09/04/2020
The hazard
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, according to the FDA.
Context
GovInfoNow's records show Stryker GmbH has 20 other recalls on record since 2018-03-12. Other recent recalls of similar products include Stryker Hoffmann II Connecting Rod Micro 3 x 90mm (2026-07-01), Stryker Gamma4 Right Long Nail Recall (2025-05-28), and Stryker Femoral Nail Left/Right Mixup Recall (2025-05-22). Additional recent recalls include Stryker NICO BrainPath Shephard's Hook Recall (2025-10-31), Howmedica Osteonics recalls cobalt chrome elbow implants with potential wear debris risk (2026-07-30), and Stryker NICO Myriad Handpieces Recall (2025-10-31).
How to tell if you have this one
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.
Brand
Stryker
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Numbers
Look for product numbers like EZ15-12-12 or EZBXP10-15-13 on the device packaging or label.
Contact Stryker
Reach out to Stryker directly for assistance with the recall process or to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0457-2021 (September 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0457-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.