In2Bones Recalls DUAFIT Interphalangeal Implants Due to Dimensional Non-Conformity
In2Bones is recalling 35 units of DUAFIT PIP 0o CA Size 2 interphalangeal implants because dimensional non-conformity prevents them from fitting into the dedicated holder.
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 the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (inability to fit the holder) rather than a direct safety risk like infection or injury, aligning with the Moderate severity criteria for low-risk issues or voluntary precautionary recalls without reported harm.
Plain-English summary
In2Bones, SAS is recalling 35 units of DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, interphalangeal implants. The recall is due to dimensional non-conformity, which makes it impossible to introduce the implant into the dedicated holder.
The affected units have batch numbers 1404032 and 1412011. The products were distributed in the state of Tennessee. The recall is classified as Class II by the FDA.
Healthcare providers should stop using the affected implants and contact In2Bones, SAS for further instructions.
The recalled product
- Product
- DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
- Manufacturer
- In2Bones, SAS
- Affected units
- 35
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 (2)
- Batch numbers: 1404032
- 1412011
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by In2Bones, SAS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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