In2Bones Recalls DUAFIT Interphalangeal Implants Due to Dimensional Non-Conformity
In2Bones is recalling 15 DUAFIT interphalangeal implants because dimensional non-conformity prevents them from fitting into their dedicated holders.
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 hazard involves a functional defect (inability to fit holder) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
In2Bones, SAS is recalling 15 units of DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only interphalangeal implants. The recall is due to dimensional non-conformity, which makes it impossible to introduce the implant into its dedicated holder.
The affected units are identified by batch number 1412021. The products were distributed in the state of Tennessee.
Consumers and healthcare providers should stop using these implants and contact In2Bones, SAS for further instructions.
The recalled product
- Product
- DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
- Manufacturer
- In2Bones, SAS
- Hazard
- Affected units
- 15
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)
- Batch numbers: 1412021
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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