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Recall Observatory FDA recall evidence

Device product

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

Z-0843-2024

August 08, 2023

Class II

Product summary

Firm
FX SHOULDER
Event
Event 93729
Status
Ongoing
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0843-2024

Official wording

Reason: Centered glenosphere box may contain an eccentric glenosphere.

Code information: UDI-DI: 03701037309551, Lot: U0191

Distribution pattern: US Nationwide distribution in the state of NJ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Centered glenosphere box may contain an eccentric glenosphere.