Yecla, Spain
GRAPHENANO DENTAL SL recalls
1 recall recorded since 2018, most recently on 24 October 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
- 24 October 2023
- Reason
- Machining error on cams renders the device unusable.
- Distribution
- US Nationwide distribution in the state of Utah.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1192-2024
- GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 2
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.