FDA-Device2015-12-16Class II

IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

In2Bones, SAS
Hazard

One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.

Sold states
US Distribution to the state of :TN
Affected count
20 units
Manufactured in
28 Chemin Du Petit Bois, N/A, Ecully, N/A, France
Products
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0397-2016

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