FDA-Device2015-04-01Class II

DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.

In2Bones, SAS
Hazard

Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

Sold states
Distributed in the state of TN.
Affected count
35 units
Manufactured in
28 Chemin Du Petit Bois, Ecully, France
Products
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2015

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