X Spine Systems Recalls Serrated Soft Tissue Shields for Spinal Surgery
X Spine Systems Inc is recalling Serrated Soft Tissue Shields from the Silex Sacroiliac Fusion System because Revision B is 7 mm longer than the previous design.
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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
X Spine Systems Inc is recalling Serrated Soft Tissue Shields, which are orthopedic surgical instruments used as guides in the Silex Sacroiliac Joint Fusion System for spinal surgery. The recall involves part numbers X079-0096 and X079-0097 with Lot #12320.
The reason for the recall is that Revision B of the tissue shields was 7 mm longer than the previous design. A total of 5 pieces of each part number were distributed in the United States, including the states of Florida and Missouri.
Healthcare providers and facilities that have received these devices should stop using them and contact X Spine Systems Inc for further instructions.
The recalled product
- Product
- Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
- Manufacturer
- X Spine Systems Inc
- Hazard
- Affected units
- 5
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)
- Part numbers X079-0096 and X079-0097 with Lot #12320
Distribution
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