Medical device recalls Moderate risk

In2Bones, SAS recalls IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

Recall date
November 18, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0397-2016
FDA classification
Class II
Brand / firm
In2Bones, SAS
Sold / distributed
US Distribution to the state of :TN

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

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