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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

GRAPHENANO DENTAL SL: G-CAM Dental Machining Discs Recalled Due to Machining Errors

Agency Publication Date: February 28, 2024
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Summary

Graphenano Dental SL is recalling 354 units of its G-CAM multichroma dental discs used in the manufacture of dentures. A machining error on the device's cams has been identified, which renders the product completely unusable for its intended dental applications. Consumers and dental professionals should check their inventory for specific reference and lot numbers included in this recall. If you possess an affected disc, you should contact the manufacturer immediately as the defect prevents the device from functioning correctly.

Risk

A manufacturing defect during the machining of the cams makes the dental discs unusable. This defect prevents the proper creation of dental prosthetics, potentially leading to delays in patient treatment or the need for replacement materials.

What You Should Do

  1. Check your product inventory for G-CAM 95 Multichroma dental discs with the following Reference (REF) and Lot numbers: REF GC00089 (Lot L2309099), REF GC00112 (Lot L2309119), REF GC00130 (Lot L2309124), REF GC00090 (Lot L2309100), REF GC00113 (Lot L2309120), REF GC00131 (Lot L2309125), REF GC00157 (Lot L2309101), REF GC00098 (Lot L2309115), REF GC00114 (Lot L2309121), REF GC00132 (Lot L2309126), REF GC00158 (Lot L2309102), REF GC00099 (Lot L2309116), REF GC00115 (Lot L2309122), REF GC00133 (Lot L2309127), REF GC00091 (Lot L2309103), REF GC00134 (Lot L2309128), REF GC00092 (Lot L2309504), REF GC00101 (Lot L2309117), REF GC00117 (Lot L2309177), REF GC00135 (Lot L2309130), REF GC00094 (Lot L2309105), REF GC00119 (Lot L2309123), REF GC00137 (Lot L2309131), REF GC00095 (Lot L2309106), REF GC00104 (Lot L2309132), and REF GC00138 (Lot L2309133).
  2. Stop using any dental discs that match the identified Reference and Lot numbers immediately as they are unusable due to machining errors.
  3. Contact Graphenano Dental SL or your healthcare provider to discuss the impact of this defect on your practice and to arrange for any necessary replacements or further instructions.
  4. For additional information or questions regarding this device recall, contact the FDA directly at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall due to unusable product.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: 95 Multichroma 14LB2
Model / REF:
GC00089
UPC Codes:
8445644002447
Lot Numbers:
L2309099
Product: 95 Multichroma 24LA2
Model / REF:
GC00112
UPC Codes:
8445644001549
Lot Numbers:
L2309119
Product: 95 Multichroma 20LA1
Model / REF:
GC00130
UPC Codes:
8445644000146
Lot Numbers:
L2309124
Product: 95 Multichroma 24LC2
Model / REF:
GC00090
UPC Codes:
8445644002553
Lot Numbers:
L2309100
Product: 95 Multichroma 24LA1
Model / REF:
GC00113
UPC Codes:
8445644001655
Lot Numbers:
L2309120
Product: 95 Multichroma 16LB2
Model / REF:
GC00131
UPC Codes:
8445644000276
Lot Numbers:
L2309125
Product: 95 Multichroma 14LA2
Model / REF:
GC00157
UPC Codes:
8445644002867
Lot Numbers:
L2309101
Product: 95 Multichroma 20LB2
Model / REF:
GC00098
UPC Codes:
8445644000153
Lot Numbers:
L2309115
Product: 95 Multichroma 20LBL2
Model / REF:
GC00114
UPC Codes:
8445644001747
Lot Numbers:
L2309121
Product: 95 Multichroma 16LA3,5
Model / REF:
GC00132
UPC Codes:
8445644000344
Lot Numbers:
L2309126
Product: 95 Multichroma 14LA1
Model / REF:
GC00158
UPC Codes:
8445644002935
Lot Numbers:
L2309102
Product: 95 Multichroma 24LB1
Model / REF:
GC00099
UPC Codes:
8445644000269
Lot Numbers:
L2309116
Product: 95 Multichroma 20LA3,5
Model / REF:
GC00115
UPC Codes:
8445644001853
Lot Numbers:
L2309122
Product: 95 Multichroma 16LA3
Model / REF:
GC00133
UPC Codes:
8445644000474
Lot Numbers:
L2309127
Product: 95 Multichroma 16LC2
Model / REF:
GC00091
UPC Codes:
8445644002645
Lot Numbers:
L2309103
Product: 95 Multichroma 14LBL2
Model / REF:
GC00134
UPC Codes:
8445644000542
Lot Numbers:
L2309128
Product: 95 Multichroma 24LBL2
Model / REF:
GC00092
UPC Codes:
8445644002751
Lot Numbers:
L2309504
Product: 95 Multichroma 24LA3,5
Model / REF:
GC00101
UPC Codes:
8445644000467
Lot Numbers:
L2309117
Product: 95 Multichroma 20LA3
Model / REF:
GC00117
UPC Codes:
8445644002058
Lot Numbers:
L2309177
Product: 95 Multichroma 14LB1
Model / REF:
GC00135
UPC Codes:
8445644000672
Lot Numbers:
L2309130
Product: 95 Multichroma 24LB2
Model / REF:
GC00094
UPC Codes:
8445644002959
Lot Numbers:
L2309105
Product: 95 Multichroma 20LA2
Model / REF:
GC00119
UPC Codes:
8445644002256
Lot Numbers:
L2309123
Product: 95 Multichroma 14LA3,5
Model / REF:
GC00137
UPC Codes:
8445644000870
Lot Numbers:
L2309131
Product: 95 Multichroma 14LC2
Model / REF:
GC00095
UPC Codes:
8445644003048
Lot Numbers:
L2309106
Product: 95 Multichroma 24LA3
Model / REF:
GC00104
UPC Codes:
8445644000757
Lot Numbers:
L2309132
Product: 95 Multichroma 14LA3
Model / REF:
GC00138
UPC Codes:
8445644000948
Lot Numbers:
L2309133

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93943
Status: Active
Manufacturer: GRAPHENANO DENTAL SL
Sold By: Dental professional distributors
Manufactured In: Spain
Units Affected: 354 units
Distributed To: Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.