Peachtree City, GA, United States
Arrowhead DE LLC recalls
1 recall recorded since 2018, most recently on 23 June 2026. 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
- 23 June 2026
- Reason
- Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
- Distribution
- US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2958-2026
- Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-
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.