FDA recall Z-0843-2024

FX SHOULDER · Class II · device

Product

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

Reason for recall

Centered glenosphere box may contain an eccentric glenosphere.

Distribution

US Nationwide distribution in the state of NJ.

Key facts

Status
Ongoing
Initiation date
2023-08-08
Report date
2024-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0843-2024