FDA Medical devices recall ·
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System recall
- Recall number
- Z-1914-2025
- Date
- (initiated May 28, 2025)
- Company / brand
- Stryker GmbH
Bohnackerweg 1, Selzach, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Why was it recalled?
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Distribution
Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
States: Alabama Florida New Jersey Oregon
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1914-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.