[pending] Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following si
Pending LLM rewrite. Source: FDA_DEVICE Z-0478-2026.
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
Polyaxial screws do not meet performance standards.
The recalled product
- Product
- Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC
- Manufacturer
- Orthofix U.S. LLC
- 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 (4)
- JP2799B
- JP2800B
- JP2659B
- JP2794B
Distribution
Distributed nationwide across the United States.
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