S.I.N. Implant System Dental Implants Recalled for Improper Storage Conditions

Agency Publication Date: October 1, 2025

Summary

S.I.N. Implant System Ltda is recalling 4,367 dental implants, including Epikut Plus and Unitite Morse Compact models. These medical devices were imported under temperature and storage conditions that did not comply with product labeling instructions. This could result in packaging damage that compromises the quality, sterility, and performance of the implants.

Risk

Improper storage conditions can cause damage to the sterile packaging of the implants. This damage could lead to contamination or reduce the overall effectiveness and safety of the device when used in dental procedures.

What You Should Do

This recall affects approximately 4,367 S.I.N. Implant System dental implants, specifically model series Epikut Plus, Epikut, and Unitite Morse Compact.
Identify your product by checking the reference number (REF) on the box label, which includes codes such as ILM 3510N, ILM 3511N, ILM 3513N, ILM 3515N, ILM 3810N, ILM 3811N, ILM 3815N, ILM 4010N, ILM 4011N, ILM 4013N, ILM 4020N, ILM 4085N, ILM 4513N, ILM 4515N, ILM 4585N, ILM 5010N, ILM 5011N, ILM 4510N, ILM 5013N, ILM 5015N, ILM 5085N, ILM 4018N, ILM 3818N, ILM 4511N, ILM 4515, ILM 4585, ILM 3813, ILM 3815, ILM 5085, ILM 3811, ILM 3820N, ILM 4518N, and UCMC 6007N. See the Affected Products section below for the full list of affected codes.
Stop using the recalled devices immediately.
Contact S.I.N. Implant System Ltda or your authorized distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: IMPLANT EPIKUT PLUS MT16 3,5X10,0MM

Variants: 3,5X10,0MM

Model / REF:

ILM 3510N

UPC Codes:

7899995277558

Lot Numbers:

X010469795 (Exp 9/12/2026)

UDI:

7899995277558

Firm initiated recall via letter.

Product: IMPLANT EPIKUT PLUS MT16 3.8X11.5MM

Variants: 3.8X11.5MM

Model / REF:

ILM 3511N

UPC Codes:

7899995274342

Lot Numbers:

X020477141 (Exp 7/11/2027)

X040490928 (Exp 1/3/2028)

X030483330 (Exp 1/2/2028)

X030482747 (Exp 9/2/2027)

X030482813 (Exp 10/10/2027)

W100457486 (Exp 2/9/2027)

X030482750 (Exp 9/2/2027)

W020415041 (Exp 10/12/2026)

X020477137 (Exp 3/4/2027)

UDI:

7899995274342

Product: IMPLANT EPIKUT PLUS MT16 3,5X13,0MM

Variants: 3,5X13,0MM

Model / REF:

ILM 3513N

UPC Codes:

7899995274335

Lot Numbers:

W080447571 (Exp 2/4/2028)

X010469706 (Exp 3/4/2028)

X010471894 (Exp 4/11/2028)

W020415045 (Exp 1/3/2028)

X120531584 (Exp 6/5/2028)

X040490953 (Exp 5/11/2028)

Y010537386 (Exp 6/12/2028)

UDI:

7899995274335

Product: IMPLANT EPIKUT PLUS MT16 3,5X15,0MM

Variants: 3,5X15,0MM

Model / REF:

ILM 3515N

UPC Codes:

7899995280893

Lot Numbers:

W020420816 (Exp 6/12/2028)

X030484303 (Exp 10/2/2028)

X010472646 (Exp 9/12/2028)

X010472644 (Exp 8/10/2028)

X120531182 (Exp 10/5/2028)

UDI:

7899995280893

Product: IMPLANT EPIKUT PLUS MT16 3,8X10,0MM

Variants: 3,8X10,0MM

Model / REF:

ILM 3810N

UPC Codes:

7899995274274

Lot Numbers:

X120531775 (Exp 10/5/2028)

UDI:

7899995274274

Product: IMPLANT CM16 3,8 X 11MM

Variants: 3,8 X 11MM

Model / REF:

ILM 3811N

UPC Codes:

7899995274229

Lot Numbers:

X010471364 (Exp 10/12/2028)

X080513064 (Exp 12/2/2028)

X100521415 (Exp 12/2/2028)

X120531368 (Exp 2/2/2029)

X070504152 (Exp 11/5/2028)

X020478981 (Exp 10/12/2028)

X120531376 (Exp 3/2/2029)

X020478983 (Exp 11/2/202)

X010471356 (Exp 10/12/2028)

X100523193 (Exp 1/2/2029)

UDI:

7899995274229

Product: IMPLANT EPIKUT PLUS MT16 3,8X15,0MM

Variants: 3,8X15,0MM

Model / REF:

ILM 3815N

UPC Codes:

7899995274168

Lot Numbers:

X120531820 (Exp 11/2/2029)

X120531267 (Exp 11/2/2029)

X010473617 (Exp 11/2/2029)

V110406564 (Exp 10/2/2029)

UDI:

7899995274168

Product: IMPLANT EPIKUT PLUS MT16 4,0X10,0MM

Variants: 4,0X10,0MM

Model / REF:

ILM 4010N

UPC Codes:

7899995274137

Lot Numbers:

Y020538716 (Exp 14/12/2028)

X120530744 (Exp 14/12/2028)

X120530266 (Exp 14/01/2029)

UDI:

7899995274137

Product: IMPLANT EPIKUT PLUS MT16 4,0X11,5MM

Variants: 4,0X11,5MM

Model / REF:

ILM 4011N

UPC Codes:

7899995274113

Lot Numbers:

W100458406 (Exp 15/12/2028)

V110406330 (Exp 15/12/2028)

X120531292 (Exp 16/05/2028)

V110404633 (Exp 15/12/2028)

X090516009 (Exp 16/01/2029)

UDI:

7899995274113

Product: IMPLANT EPIKUT PLUS MT16 4,0X13,0MM

Variants: 4,0X13,0MM

Model / REF:

ILM 4013N

UPC Codes:

7899995274106

Lot Numbers:

W080449448 (Exp 16/08/2027)

X120531842 (Exp 17/12/2028)

X120530728 (Exp 17/12/2028)

X120530726 (Exp 17/01/2029)

X120530724 (Exp 16/12/2028)

X120530730 (Exp 17/12/2028)

Y010537900 (Exp 17/12/2028)

W090454924 (Exp 16/09/2028)

X010473946 (Exp 16/12/2028)

W100458876 (Exp 16/09/2028)

X120531618 (Exp 17/12/2028)

X090517847 (Exp 16/12/2028)

X120530300 (Exp 16/12/2028)

X120531930 (Exp 17/12/2028)

X010472967 (Exp 16/12/2028)

X090517840 (Exp 16/12/2028)

X090515626 (Exp 16/12/2028)

X090515638 (Exp 16/12/2028)

UDI:

7899995274106

Product: IMP EPIKUT PLUS LONG MT16 4,0X20,0MM

Variants: 4,0X20,0MM

Model / REF:

ILM 4020N

UPC Codes:

7899995273499

Lot Numbers:

X120530786 (Exp 17/12/2028)

UDI:

7899995273499

Product: IMPLANT EPIKUT PLUS MT16 4,0X8,5MM

Variants: 4,0X8,5MM

Model / REF:

ILM 4085N

UPC Codes:

7899995274144

Lot Numbers:

X120531822 (Exp 18/06/2028)

UDI:

7899995274144

Product: IMPLANT EPIKUT PLUS MT16 4,5X13,0MM

Variants: 4,5X13,0MM

Model / REF:

ILM 4513N

UPC Codes:

7899995274038

Lot Numbers:

X120530720 (Exp 20/03/2028)

Y010538078 (Exp 22/09/2028)

X120530722 (Exp 20/10/2027)

X120530849 (Exp 22/06/2028)

UDI:

7899995274038

Product: IMPLANT EPIKUT PLUS MT16 4,5X15,0MM

Variants: 4,5X15,0MM

Model / REF:

ILM 4515N

UPC Codes:

7899995274021

Lot Numbers:

X120530902 (Exp 23/10/2028)

X120530716 (Exp 23/07/2028)

X120530340 (Exp 23/03/2028)

UDI:

7899995274021

Product: IMPLANT EPIKUT PLUS MT16 4,5X8,5MM

Variants: 4,5X8,5MM

Model / REF:

ILM 4585N

UPC Codes:

7899995274076

Lot Numbers:

X110529195 (Exp 25/11/2028)

X110529193 (Exp 25/10/2027)

UDI:

7899995274076

Product: IMPLANT EPIKUT PLUS MT16 5,0X10,0MM

Variants: 5,0X10,0MM

Model / REF:

ILM 5010N

UPC Codes:

7899995273970

Lot Numbers:

X040490644 (Exp 26/12/2028)

X040490886 (Exp 26/12/2028)

UDI:

7899995273970

Product: IMPLANT EPIKUT PLUS MT16 5,0X11,5MM

Variants: 5,0X11,5MM

Model / REF:

ILM 5011N

UPC Codes:

7899995273963

Lot Numbers:

X120530851 (Exp 26/12/2028)

UDI:

7899995273963

Product: IMPLANT EPIKUT PLUS MT16 4,5X10,0MM

Variants: 4,5X10,0MM

Model / REF:

ILM 4510N

UPC Codes:

7899995274069

Lot Numbers:

Y010537208 (Exp 18/12/2028)

UDI:

7899995274069

Product: IMPLANT EPIKUT PLUS MT16 5,0X13,0MM

Variants: 5,0X13,0MM

Model / REF:

ILM 5013N

UPC Codes:

7899995273956

Lot Numbers:

X100522628 (Exp 27/06/2027)

UDI:

7899995273956

Product: IMPLANT EPIKUT PLUS MT16 5,0X15,0MM

Variants: 5,0X15,0MM

Model / REF:

ILM 5015N

UPC Codes:

7899995273932

Lot Numbers:

X120530844 (Exp 28/12/2028)

X040490872 (Exp 27/12/2028)

UDI:

7899995273932

Product: IMPLANT EPIKUT PLUS MT16 5,0X8,5MM

Variants: 5,0X8,5MM

Model / REF:

ILM 5085N

UPC Codes:

7899995274007

Lot Numbers:

X120530511 (Exp 28/12/2028)

X120530714 (Exp 29/01/2029)

X120530338 (Exp 28/12/2028)

Y010536031 (Exp 30/05/2028)

UDI:

7899995274007

Product: IMP EPIKUT PLUS LONG MT16 4,0X18,0MM

Variants: 4,0X18,0MM

Model / REF:

ILM 4018N

UPC Codes:

7899995273529

Lot Numbers:

Y010537853 (Exp 17/12/2028)

UDI:

7899995273529

Product: IMP EPIKUT PLUS LONG MT16 3,8X18,0MM

Variants: 3,8X18,0MM

Model / REF:

ILM 3818N

UPC Codes:

7899995280886

Lot Numbers:

Y010536867 (Exp 13/12/2028)

UDI:

7899995280886

Product: IMPLANT EPIKUT PLUS MT16 4,5X11,5MM

Variants: 4,5X11,5MM

Model / REF:

ILM 4511N

UPC Codes:

7899995274045

Lot Numbers:

X120531860 (Exp 18/12/2028)

X120531935 (Exp 18/12/2028)

X120530732 (Exp 18/12/2028)

UDI:

7899995274045

Product: IMPLANT EPIKUT MT16 4,5X15,0MM

Variants: 4,5X15,0MM

Model / REF:

ILM 4515

UPC Codes:

7899995280169

Lot Numbers:

X060497920 (Exp 23/02/2028)

X060497915 (Exp 23/01/2028)

UDI:

7899995280169

Product: IMPLANT EPIKUT MT16 4,5X8,5MM

Variants: 4,5X8,5MM

Model / REF:

ILM 4585

UPC Codes:

7899995280251

Lot Numbers:

X040490690 (Exp 24/01/2028)

X120529433 (Exp 24/01/2029)

X120529450 (Exp 24/01/2029)

UDI:

7899995280251

Product: IMPLANT EPIKUT MT16 3,8X13,0MM

Variants: 3,8X13,0MM

Model / REF:

ILM 3813

UPC Codes:

7899995280527

Lot Numbers:

Y020539359 (Exp 6/2/2029)

UDI:

7899995280527

Product: IMPLANT EPIKUT MT16 3,8X15,0MM

Variants: 3,8X15,0MM

Model / REF:

ILM 3815

UPC Codes:

7899995280473

Lot Numbers:

Y010535029 (Exp 7/2/2029)

UDI:

7899995280473

Product: IMPLANT EPIKUT MT16 5,0X8,5MM

Variants: 5,0X8,5MM

Model / REF:

ILM 5085

UPC Codes:

7899995280091

Lot Numbers:

X090516829 (Exp 28/12/2028)

UDI:

7899995280091

Product: IMPLANT EPIKUT MT16 3,8X11,5MM

Variants: 3,8X11,5MM

Model / REF:

ILM 3811

UPC Codes:

7899995280534

Lot Numbers:

X110528601 (Exp 10/10/2028)

UDI:

7899995280534

Product: IMPLANT EPIKUT PLUS MT16 3,8X20,0MM

Variants: 3,8X20,0MM

Model / REF:

ILM 3820N

UPC Codes:

7899995273642

Lot Numbers:

V110406210 (Exp 13/12/2028)

X020479077

UDI:

7899995273642

Product: IMPLANT EPIKUT PLUS MT16 4,5X18,0MM

Variants: 4,5X18,0MM

Model / REF:

ILM 4518N

UPC Codes:

7899995273437

Lot Numbers:

W060438138 (Exp 24/01/2028)

X120531278 (Exp 24/01/2028)

UDI:

7899995273437

Product: IMPLANT UNITITE MORSE COMPACT 6.0X7MM

Variants: 6.0X7MM

Model / REF:

UCMC 6007N

UPC Codes:

7899995215895

Lot Numbers:

Y010536358 (Exp 30/10/2028)

UDI:

7899995215895

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97553

Status: Active

Manufacturer: S.I.N. Implant System Ltda

Sold By: Authorized dental device distributors; Medical specialty suppliers

Manufactured In: Brazil

Units Affected: 4,367

Distributed To: Texas, Illinois, Kentucky, North Carolina, Tennessee, Colorado, California, Missouri, Maryland, Alabama, Florida, Pennsylvania, Utah, Nebraska, Idaho, Arizona, Washington, Oklahoma, Oregon, Nevada, New Jersey, Virginia, New York, Louisiana, Connecticut, South Dakota, South Carolina, Hawaii, Kansas, Massachusetts, Michigan, New Mexico, Ohio, Montana, Wisconsin, Minnesota, Maine

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 · 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.

Summary

What You Should Do

This recall affects approximately 4,367 S.I.N. Implant System dental implants, specifically model series Epikut Plus, Epikut, and Unitite Morse Compact.

Identify your product by checking the reference number (REF) on the box label, which includes codes such as ILM 3510N, ILM 3511N, ILM 3513N, ILM 3515N, ILM 3810N, ILM 3811N, ILM 3815N, ILM 4010N, ILM 4011N, ILM 4013N, ILM 4020N, ILM 4085N, ILM 4513N, ILM 4515N, ILM 4585N, ILM 5010N, ILM 5011N, ILM 4510N, ILM 5013N, ILM 5015N, ILM 5085N, ILM 4018N, ILM 3818N, ILM 4511N, ILM 4515, ILM 4585, ILM 3813, ILM 3815, ILM 5085, ILM 3811, ILM 3820N, ILM 4518N, and UCMC 6007N. See the Affected Products section below for the full list of affected codes.

Stop using the recalled devices immediately.

Contact S.I.N. Implant System Ltda or your authorized distributor to arrange for the return, replacement, or correction of any affected units in your inventory.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Affected Products

Product: IMPLANT EPIKUT PLUS MT16 3,5X10,0MM

Variants: 3,5X10,0MM

Model / REF:

ILM 3510N

UPC Codes:

7899995277558

Lot Numbers:

X010469795 (Exp 9/12/2026)

UDI:

7899995277558

Firm initiated recall via letter.

Product: IMPLANT EPIKUT PLUS MT16 3.8X11.5MM

Variants: 3.8X11.5MM

Model / REF:

ILM 3511N

UPC Codes:

7899995274342

Lot Numbers:

X020477141 (Exp 7/11/2027)

X040490928 (Exp 1/3/2028)

X030483330 (Exp 1/2/2028)

X030482747 (Exp 9/2/2027)

X030482813 (Exp 10/10/2027)

W100457486 (Exp 2/9/2027)

X030482750 (Exp 9/2/2027)

W020415041 (Exp 10/12/2026)

X020477137 (Exp 3/4/2027)

UDI:

7899995274342

Product: IMPLANT EPIKUT PLUS MT16 3,5X13,0MM

Variants: 3,5X13,0MM

Model / REF:

ILM 3513N

UPC Codes:

7899995274335

Lot Numbers:

W080447571 (Exp 2/4/2028)

X010469706 (Exp 3/4/2028)

X010471894 (Exp 4/11/2028)

W020415045 (Exp 1/3/2028)

X120531584 (Exp 6/5/2028)

X040490953 (Exp 5/11/2028)

Y010537386 (Exp 6/12/2028)

UDI:

7899995274335

Product: IMPLANT EPIKUT PLUS MT16 3,5X15,0MM

Variants: 3,5X15,0MM

Model / REF:

ILM 3515N

UPC Codes:

7899995280893

Lot Numbers:

W020420816 (Exp 6/12/2028)

X030484303 (Exp 10/2/2028)

X010472646 (Exp 9/12/2028)

X010472644 (Exp 8/10/2028)

X120531182 (Exp 10/5/2028)

UDI:

7899995280893

Product: IMPLANT EPIKUT PLUS MT16 3,8X10,0MM

Variants: 3,8X10,0MM

Model / REF:

ILM 3810N

UPC Codes:

7899995274274

Lot Numbers:

X120531775 (Exp 10/5/2028)

UDI:

7899995274274

Product: IMPLANT CM16 3,8 X 11MM

Variants: 3,8 X 11MM

Model / REF:

ILM 3811N

UPC Codes:

7899995274229

Lot Numbers:

X010471364 (Exp 10/12/2028)

X080513064 (Exp 12/2/2028)

X100521415 (Exp 12/2/2028)

X120531368 (Exp 2/2/2029)

X070504152 (Exp 11/5/2028)

X020478981 (Exp 10/12/2028)

X120531376 (Exp 3/2/2029)

X020478983 (Exp 11/2/202)

X010471356 (Exp 10/12/2028)

X100523193 (Exp 1/2/2029)

UDI:

7899995274229

Product: IMPLANT EPIKUT PLUS MT16 3,8X15,0MM

Variants: 3,8X15,0MM

Model / REF:

ILM 3815N

UPC Codes:

7899995274168

Lot Numbers:

X120531820 (Exp 11/2/2029)

X120531267 (Exp 11/2/2029)

X010473617 (Exp 11/2/2029)

V110406564 (Exp 10/2/2029)

UDI:

7899995274168

Product: IMPLANT EPIKUT PLUS MT16 4,0X10,0MM

Variants: 4,0X10,0MM

Model / REF:

ILM 4010N

UPC Codes:

7899995274137

Lot Numbers:

Y020538716 (Exp 14/12/2028)

X120530744 (Exp 14/12/2028)

X120530266 (Exp 14/01/2029)

UDI:

7899995274137

Product: IMPLANT EPIKUT PLUS MT16 4,0X11,5MM

Variants: 4,0X11,5MM

Model / REF:

ILM 4011N

UPC Codes:

7899995274113

Lot Numbers:

W100458406 (Exp 15/12/2028)

V110406330 (Exp 15/12/2028)

X120531292 (Exp 16/05/2028)

V110404633 (Exp 15/12/2028)

X090516009 (Exp 16/01/2029)

UDI:

7899995274113

Product: IMPLANT EPIKUT PLUS MT16 4,0X13,0MM

Variants: 4,0X13,0MM

Model / REF:

ILM 4013N

UPC Codes:

7899995274106

Lot Numbers:

W080449448 (Exp 16/08/2027)

X120531842 (Exp 17/12/2028)

X120530728 (Exp 17/12/2028)

X120530726 (Exp 17/01/2029)

X120530724 (Exp 16/12/2028)

X120530730 (Exp 17/12/2028)

Y010537900 (Exp 17/12/2028)

W090454924 (Exp 16/09/2028)

X010473946 (Exp 16/12/2028)

W100458876 (Exp 16/09/2028)

X120531618 (Exp 17/12/2028)

X090517847 (Exp 16/12/2028)

X120530300 (Exp 16/12/2028)

X120531930 (Exp 17/12/2028)

X010472967 (Exp 16/12/2028)

X090517840 (Exp 16/12/2028)

X090515626 (Exp 16/12/2028)

X090515638 (Exp 16/12/2028)

UDI:

7899995274106

Product: IMP EPIKUT PLUS LONG MT16 4,0X20,0MM

Variants: 4,0X20,0MM

Model / REF:

ILM 4020N

UPC Codes:

7899995273499

Lot Numbers:

X120530786 (Exp 17/12/2028)

UDI:

7899995273499

Product: IMPLANT EPIKUT PLUS MT16 4,0X8,5MM

Variants: 4,0X8,5MM

Model / REF:

ILM 4085N

UPC Codes:

7899995274144

Lot Numbers:

X120531822 (Exp 18/06/2028)

UDI:

7899995274144

Product: IMPLANT EPIKUT PLUS MT16 4,5X13,0MM

Variants: 4,5X13,0MM

Model / REF:

ILM 4513N

UPC Codes:

7899995274038

Lot Numbers:

X120530720 (Exp 20/03/2028)

Y010538078 (Exp 22/09/2028)

X120530722 (Exp 20/10/2027)

X120530849 (Exp 22/06/2028)

UDI:

7899995274038

Product: IMPLANT EPIKUT PLUS MT16 4,5X15,0MM

Variants: 4,5X15,0MM

Model / REF:

ILM 4515N

UPC Codes:

7899995274021

Lot Numbers:

X120530902 (Exp 23/10/2028)

X120530716 (Exp 23/07/2028)

X120530340 (Exp 23/03/2028)

UDI:

7899995274021

Product: IMPLANT EPIKUT PLUS MT16 4,5X8,5MM

Variants: 4,5X8,5MM

Model / REF:

ILM 4585N

UPC Codes:

7899995274076

Lot Numbers:

X110529195 (Exp 25/11/2028)

X110529193 (Exp 25/10/2027)

UDI:

7899995274076

Product: IMPLANT EPIKUT PLUS MT16 5,0X10,0MM

Variants: 5,0X10,0MM

Model / REF:

ILM 5010N

UPC Codes:

7899995273970

Lot Numbers:

X040490644 (Exp 26/12/2028)

X040490886 (Exp 26/12/2028)

UDI:

7899995273970

Product: IMPLANT EPIKUT PLUS MT16 5,0X11,5MM

Variants: 5,0X11,5MM

Model / REF:

ILM 5011N

UPC Codes:

7899995273963

Lot Numbers:

X120530851 (Exp 26/12/2028)

UDI:

7899995273963

Product: IMPLANT EPIKUT PLUS MT16 4,5X10,0MM

Variants: 4,5X10,0MM

Model / REF:

ILM 4510N

UPC Codes:

7899995274069

Lot Numbers:

Y010537208 (Exp 18/12/2028)

UDI:

7899995274069

Product: IMPLANT EPIKUT PLUS MT16 5,0X13,0MM

Variants: 5,0X13,0MM

Model / REF:

ILM 5013N

UPC Codes:

7899995273956

Lot Numbers:

X100522628 (Exp 27/06/2027)

UDI:

7899995273956

Product: IMPLANT EPIKUT PLUS MT16 5,0X15,0MM

Variants: 5,0X15,0MM

Model / REF:

ILM 5015N

UPC Codes:

7899995273932

Lot Numbers:

X120530844 (Exp 28/12/2028)

X040490872 (Exp 27/12/2028)

UDI:

7899995273932

Product: IMPLANT EPIKUT PLUS MT16 5,0X8,5MM

Variants: 5,0X8,5MM

Model / REF:

ILM 5085N

UPC Codes:

7899995274007

Lot Numbers:

X120530511 (Exp 28/12/2028)

X120530714 (Exp 29/01/2029)

X120530338 (Exp 28/12/2028)

Y010536031 (Exp 30/05/2028)

UDI:

7899995274007

Product: IMP EPIKUT PLUS LONG MT16 4,0X18,0MM

Variants: 4,0X18,0MM

Model / REF:

ILM 4018N

UPC Codes:

7899995273529

Lot Numbers:

Y010537853 (Exp 17/12/2028)

UDI:

7899995273529

Product: IMP EPIKUT PLUS LONG MT16 3,8X18,0MM

Variants: 3,8X18,0MM

Model / REF:

ILM 3818N

UPC Codes:

7899995280886

Lot Numbers:

Y010536867 (Exp 13/12/2028)

UDI:

7899995280886

Product: IMPLANT EPIKUT PLUS MT16 4,5X11,5MM

Variants: 4,5X11,5MM

Model / REF:

ILM 4511N

UPC Codes:

7899995274045

Lot Numbers:

X120531860 (Exp 18/12/2028)

X120531935 (Exp 18/12/2028)

X120530732 (Exp 18/12/2028)

UDI:

7899995274045

Product: IMPLANT EPIKUT MT16 4,5X15,0MM

Variants: 4,5X15,0MM

Model / REF:

ILM 4515

UPC Codes:

7899995280169

Lot Numbers:

X060497920 (Exp 23/02/2028)

X060497915 (Exp 23/01/2028)

UDI:

7899995280169

Product: IMPLANT EPIKUT MT16 4,5X8,5MM

Variants: 4,5X8,5MM

Model / REF:

ILM 4585

UPC Codes:

7899995280251

Lot Numbers:

X040490690 (Exp 24/01/2028)

X120529433 (Exp 24/01/2029)

X120529450 (Exp 24/01/2029)

UDI:

7899995280251

Product: IMPLANT EPIKUT MT16 3,8X13,0MM

Variants: 3,8X13,0MM

Model / REF:

ILM 3813

UPC Codes:

7899995280527

Lot Numbers:

Y020539359 (Exp 6/2/2029)

UDI:

7899995280527

Product: IMPLANT EPIKUT MT16 3,8X15,0MM

Variants: 3,8X15,0MM

Model / REF:

ILM 3815

UPC Codes:

7899995280473

Lot Numbers:

Y010535029 (Exp 7/2/2029)

UDI:

7899995280473

Product: IMPLANT EPIKUT MT16 5,0X8,5MM

Variants: 5,0X8,5MM

Model / REF:

ILM 5085

UPC Codes:

7899995280091

Lot Numbers:

X090516829 (Exp 28/12/2028)

UDI:

7899995280091

Product: IMPLANT EPIKUT MT16 3,8X11,5MM

Variants: 3,8X11,5MM

Model / REF:

ILM 3811

UPC Codes:

7899995280534

Lot Numbers:

X110528601 (Exp 10/10/2028)

UDI:

7899995280534

Product: IMPLANT EPIKUT PLUS MT16 3,8X20,0MM

Variants: 3,8X20,0MM

Model / REF:

ILM 3820N

UPC Codes:

7899995273642

Lot Numbers:

V110406210 (Exp 13/12/2028)

X020479077

UDI:

7899995273642

Product: IMPLANT EPIKUT PLUS MT16 4,5X18,0MM

Variants: 4,5X18,0MM

Model / REF:

ILM 4518N

UPC Codes:

7899995273437

Lot Numbers:

W060438138 (Exp 24/01/2028)

X120531278 (Exp 24/01/2028)

UDI:

7899995273437

Product: IMPLANT UNITITE MORSE COMPACT 6.0X7MM

Variants: 6.0X7MM

Model / REF:

UCMC 6007N

UPC Codes:

7899995215895

Lot Numbers:

Y010536358 (Exp 30/10/2028)

UDI:

7899995215895

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97553

Status: Active

Manufacturer: S.I.N. Implant System Ltda

Sold By: Authorized dental device distributors; Medical specialty suppliers

Manufactured In: Brazil

Units Affected: 4,367