In2Bones Recalls Osteosynthesis Screws with Incorrect Torx Imprint
In2Bones is recalling 20 units of Model S25 ST014 osteosynthesis screws distributed in Tennessee because they were manufactured with the incorrect Torx imprint on the screw head.
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 defect is a manufacturing error (incorrect imprint) that does not explicitly report injuries or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
In2Bones, SAS is recalling 20 units of IBS Osteosynthesis screws for bone fixation, Model S25 ST014. The recall was initiated because one batch of these screws was manufactured with the incorrect Torx imprint on the screw head.
The affected units were distributed in the United States to the state of Tennessee. The specific code for the recalled units is 1509058.
Healthcare providers and consumers should stop using these specific screws and contact the recalling firm for further instructions.
The recalled product
- Product
- IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
- Manufacturer
- In2Bones, SAS
- Hazard
- Affected units
- 20
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)
- 1509058
Distribution
Distributed in 1 state:
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