The Recall Desk
HighFDA (Devices)·Z-1914-2025·Announced 2025-06-18

Stryker Gamma4 Right Long Nails Recalled for Wrong Geometry Manufacturing Defect

Stryker is recalling certain Gamma4 Long Nails because right-side nails were manufactured with left-side geometry, which could affect proper surgical placement.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a medical device manufacturing defect (FDA Class II) where a surgical implant was produced with incorrect geometry that could compromise surgical placement. No illnesses or injuries have been reported, but the defect represents a clear risk of harm in surgical applications.

Plain-English summary

Stryker GmbH is recalling the Gamma4 Long Nail, RIGHT (Catalog Number 84250320S, Lot K1BC9B7), a component of the Gamma4 System orthopedic device. Investigation confirmed that right-side nails were manufactured with left-side geometry, which could affect proper surgical placement and positioning during bone fixation procedures.

The affected product was distributed worldwide with US distribution in Alabama, Florida, New Jersey, and Oregon. Healthcare providers should contact Stryker for instructions regarding replacement or management of affected implants. Patients who have received this implant should consult their healthcare provider if they have concerns.

The recalled product

Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Implant
Hazard
  • manufacturing-defect
  • implant-geometry-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.

Distribution

Distributed nationwide across the United States.

Related recalls

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