Medical device recalls Moderate risk

FX SHOULDER recalls Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

Recall date
August 8, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0843-2024
FDA classification
Class II
Brand / firm
FX SHOULDER
Sold / distributed
US Nationwide distribution in the state of NJ.

Why it was recalled

Centered glenosphere box may contain an eccentric glenosphere.

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

What was recalled

Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

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