Virage OCT Spinal Fixation System Recall for Updated Surgical Guidance
Zimmer Spine is issuing a Class II correction for the Virage OCT Spinal Fixation System to provide additional guidance in the surgical technique manual.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II but is a voluntary precautionary correction involving documentation updates (surgical manual) with no reported injuries or illnesses, fitting the Moderate criteria for low-risk or documentation issues.
Plain-English summary
Zimmer Spine, Inc. is initiating a Medical Device Correction for the Virage OCT Spinal Fixation System. This system is intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3). The correction involves providing additional guidance in the Virage OCT Surgical Technique Manual.
The recall affects 15,753 units of the Virage OCT Spinal Fixation System. These devices were distributed nationwide in the United States, as well as in Australia and Germany. The specific code associated with the manual is L1637 Rev B (2014-06).
This action is classified as a Class II recall by the FDA. No specific injuries, illnesses, or deaths are reported in the source text. The correction is procedural, aimed at updating the surgical technique manual to provide additional guidance to users.
The recalled product
- Product
- Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
- Manufacturer
- Zimmer Spine, Inc.
- Category
- Medical Device — Spinal Fixation
- Hazard
- Affected units
- 15,753
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)
- Surgical Technique Manual L1637 Rev B (2014-06)
Distribution
Distributed nationwide across the United States.
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