In2Bones, SAS recalls DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
- Recall date
- March 9, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1318-2015
- FDA classification
- Class II
- Brand / firm
- In2Bones, SAS
- Sold / distributed
- Distributed in the state of TN.
Why it was recalled
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
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