[pending] Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Pending LLM rewrite. Source: FDA_DEVICE Z-1914-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
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 — Devices
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.
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