Lower riskMedical device recall · FDA · Published May 28, 2025
Stryker Gamma4 Right Long Nail Recall: Wrong Nail Geometry Risk
Stryker recalls Gamma4 Right Long Nail (catalog 84250320S) due to being manufactured with left nail geometry. This could cause improper function in surgical procedures.
“Stryker Gamma4 Right Long Nail Recall: Wrong Nail Geometry Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52208-stryker-gamma4-right-long-nail-recall-wrong-nail-geometry-risk. Based on FDA recall #Z-1914-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1914-2025%22&limit=1).
The FDA announced on May 28, 2025, that Stryker GmbH voluntarily recalled Long Nail, RIGHT Gamma4 10x320mm x 125 components of the Gamma4 System. The hazard is that the right nail was manufactured with left geometry.
How to tell if you have it
Brand: Stryker
Product: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System
Catalog Number: 84250320S
UPC: 07613327479515
Lot Number: K1BC9B7
Distribution: US states of AL, FL, NJ, OR; Australia and Japan
The hazard
The investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Context
GovInfoNow's records show Stryker GmbH has 20 other recalls on record since 2018-03-12. Recent similar recalls include the Stryker Femoral Nail Left/Right Mixup Recall (2025-05-22) and the Stryker Guide Wire with Ruler Tube 3x800 mm DIA recall (2025-03-28). Other recent recalls of similar products include the Smith & Nephew TRIGEN Humeral Nail Recall (2026-03-16), the Waldemar Link Knee Fusion Nail Recall (2025-11-10), and the Tornier Perip Screw Recall (2025-12-19).
How to tell if you have this one
Check for the catalog number 84250320S on the nail packaging or label. The product is part of the Gamma4 System and was sold with lot number K1BC9B7.
Brand
Stryker
Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the catalog number 84250320S on the nail packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Florida, New Jersey, Oregon.
Recall timeline
FDA published this recall 21 days 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-1914-2025 (May 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1914-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.