Spinal fixation screws recalled for not meeting performance standards
Orthofix is recalling 624 Virata preassembled polyaxial screws used in the Virata Spinal Fixation System because the screws do not meet performance standards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: an implanted load-bearing screw that fails its performance standard is a hazard, and no injuries are reported.
Plain-English summary
Virata Preassembled Polyaxial Screws, used in the Virata Spinal Fixation System, are being recalled across sizes including the 5.5 mm x 30 mm screw (item TL1-10755030) and the 5.5 mm x 35 mm screw (item TL1-10755035).
The polyaxial screws do not meet performance standards.
The recall covers 624 units, including UDI-DI 10889981335229 from lot JP2572B, distributed in California, North Carolina and Texas. The FDA has classified the action as Class II.
A spinal implant that falls short of its performance standard is a concern because it is load-bearing once placed. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Orthofix's instructions.
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…
- Manufacturer
- Orthofix U.S. LLC
- Category
- Medical Device — Spinal implant
- Affected units
- 624
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
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