Recall Record

Dallas, TX, United States

FX SHOULDER recalls

1 recall recorded since 2018, most recently on 8 August 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
8 August 2023
Reason
Centered glenosphere box may contain an eccentric glenosphere.
Distribution
US Nationwide distribution in the state of NJ.
Initiated
Voluntary: Firm initiated
Recall number
Z-0843-2024

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.