# FDA recall Z-1192-2024

> **GRAPHENANO DENTAL SL** · Class II · device recall initiated 2023-10-24.

## Product

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 24LA1, REF GC00113;   f) 95 Multichroma 16LB2, REF GC00131;   g) 95 Multichroma 14LA2, REF GC00157;   h) 95 Multichroma 20LB2, REF GC00098;   i) 95 Multichroma 20LBL2, REF GC00114;   j) 95 Multichroma 16LA3,5, REF GC00132;   k) 95 Multichroma 14LA1, REF GC00158;   l) 95 Multichroma 24LB1, REF GC00099;   m) 95 Multichroma 20LA3,5, REF GC00115;   n) 95 Multichroma 16LA3, REF GC00133;   o) 95 Multichroma 16LC2, REF GC00091;   p) 95 Multichroma 14LBL2, REF GC00134;   q) 95 Multichroma 24LBL2, REF GC00092;   r) 95 Multichroma 24LA3,5, REF GC00101;   s) 95 Multichroma 20LA3, REF GC00117;   t) 95 Multichroma 14LB1, REF GC00135;   u) 95 Multichroma 24LB2, REF GC00094;   v) 95 Multichroma 20LA2, REF GC00119;   w) 95 Multichroma14LA3,5, REF GC00137;   x) 95 Multichroma 14LC2, REF 

## Reason for recall

Machining error on cams renders the device unusable.

## Distribution

US Nationwide distribution in the state of Utah.

## Key facts

- **Recall number:** Z-1192-2024
- **Recalling firm:** GRAPHENANO DENTAL SL
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-24
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yecla, Spain

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1192-2024

## Citation

> AI Analytics. FDA recall Z-1192-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1192-2024. Source: US FDA. Licensed CC0.

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