🔍 RecallPedia

IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N

Class I - Dangerous
🏥 Medical Devices Recalled: July 30, 2025 S.I.N. Implant System Ltda Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    REF/UDI-DI/Lot(Expiration): ILM 3510N/7899995277558/X010469795(9/12/2026); ILM 3511N/7899995274342/X020477141(7/11/2027), X040490928(1/3/2028), X030483330(1/2/2028), X030482747(9/2/2027), X030482813(10/10/2027), W100457486(2/9/2027), X030482750(9/2/2027), W020415041(10/12/2026), X020477137(3/4/2027); ILM 3513N/7899995274335/W080447571(2/4/2028), X010469706(3/4/2028), X010471894(4/11/2028), W020415045(1/3/2028), X120531584(6/5/2028), X040490953(5/11/2028), Y010537386(6/12/2028); ILM 3515N/7899995280893/W020420816(6/12/2028), X030484303(10/2/2028), X010472646(9/12/2028), X010472644(8/10/2028), X120531182(10/5/2028); ILM 3810N/7899995274274/X120531775(10/5/2028); ILM 3811N/7899995274229/X010471364(10/12/2028), X080513064(12/2/2028), X100521415(12/2/2028), X120531368(2/2/2029), X070504152(11/5/2028), X020478981(10/12/2028), X120531376(3/2/2029), X020478983(11/2/202), X010471356(10/12/2028), X100523193(1/2/2029); ILM 3815N/7899995274168/X120531820(11/2/2029), X120531267(11/2/2029), X010473617(11/2/2029), V110406564(10/2/2029); ILM 4010N/7899995274137/Y020538716(14/12/2028), X120530744(14/12/2028), X120530266(14/01/2029); ILM 4011N/7899995274113/W100458406(15/12/2028), V110406330(15/12/2028), X120531292(16/05/2028), V110404633(15/12/2028), X090516009(16/01/2029); ILM 4013N/7899995274106/W080449448(16/08/2027), X120531842(17/12/2028), X120530728(17/12/2028), X120530726(17/01/2029), X120530724(16/12/2028), X120530730(17/12/2028), Y010537900(17/12/2028), W090454924(16/09/2028), X010473946(16/12/2028), W100458876(16/09/2028), X120531618(17/12/2028), X090517847(16/12/2028), X120530300(16/12/2028), X120531930(17/12/2028), X010472967(16/12/2028), X090517840(16/12/2028), X090515626(16/12/2028), X090515638(16/12/2028); ILM 4020N/7899995273499/X120530786(17/12/2028); ILM 4085N/7899995274144/X120531822(18/06/2028); ILM 4513N/7899995274038/X120530720(20/03/2028), Y010538078(22/09/2028), X120530722(20/10/2027), X120530849(22/06/2028); ILM 4515N/7899995274021/X120530902(23/10/2028), X120530716(23/07/2028), X120530340(23/03/2028); ILM 4585N/7899995274076/X110529195(25/11/2028), X110529193(25/10/2027); ILM 5010N/7899995273970/X040490644(26/12/2028), X040490886(26/12/2028); ILM 5011N/7899995273963/X120530851(26/12/2028); ILM 4510N/7899995274069/Y010537208(18/12/2028); ILM 5013N/7899995273956/X100522628(27/06/2027); ILM 5015N/7899995273932/X120530844(28/12/2028), X040490872(27/12/2028); ILM 5085N/7899995274007/X120530511(28/12/2028), X120530714(29/01/2029), X120530338(28/12/2028), Y010536031(30/05/2028); ILM 4018N/7899995273529/Y010537853(17/12/2028); ILM 3818N/7899995280886/Y010536867(13/12/2028); ILM 4511N/7899995274045/X120531860(18/12/2028), X120531935(18/12/2028), X120530732(18/12/2028); ILM 4515/7899995280169/X060497920(23/02/2028), X060497915(23/01/2028); ILM 4585/7899995280251/X040490690(24/01/2028), X120529433(24/01/2029), X120529450(24/01/2029); ILM 3813/7899995280527/Y020539359(6/2/2029); ILM 3815/7899995280473/Y010535029(7/2/2029); ILM 5085/7899995280091/X090516829(28/12/2028); ILM 3811/7899995280534/X110528601(10/10/2028); ILM 3820N/7899995273642/V110406210(13/12/2028), X020479077(X020479077); ILM 4518N/7899995273437/W060438138(24/01/2028), X120531278(24/01/2028); UCMC 6007N/7899995215895/Y010536358(30/10/2028);
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
S.I.N. Implant System Ltda
Reason for Recall:
Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N

Product Codes/Lot Numbers:

REF/UDI-DI/Lot(Expiration): ILM 3510N/7899995277558/X010469795(9/12/2026); ILM 3511N/7899995274342/X020477141(7/11/2027), X040490928(1/3/2028), X030483330(1/2/2028), X030482747(9/2/2027), X030482813(10/10/2027), W100457486(2/9/2027), X030482750(9/2/2027), W020415041(10/12/2026), X020477137(3/4/2027); ILM 3513N/7899995274335/W080447571(2/4/2028), X010469706(3/4/2028), X010471894(4/11/2028), W020415045(1/3/2028), X120531584(6/5/2028), X040490953(5/11/2028), Y010537386(6/12/2028); ILM 3515N/7899995280893/W020420816(6/12/2028), X030484303(10/2/2028), X010472646(9/12/2028), X010472644(8/10/2028), X120531182(10/5/2028); ILM 3810N/7899995274274/X120531775(10/5/2028); ILM 3811N/7899995274229/X010471364(10/12/2028), X080513064(12/2/2028), X100521415(12/2/2028), X120531368(2/2/2029), X070504152(11/5/2028), X020478981(10/12/2028), X120531376(3/2/2029), X020478983(11/2/202), X010471356(10/12/2028), X100523193(1/2/2029); ILM 3815N/7899995274168/X120531820(11/2/2029), X120531267(11/2/2029), X010473617(11/2/2029), V110406564(10/2/2029); ILM 4010N/7899995274137/Y020538716(14/12/2028), X120530744(14/12/2028), X120530266(14/01/2029); ILM 4011N/7899995274113/W100458406(15/12/2028), V110406330(15/12/2028), X120531292(16/05/2028), V110404633(15/12/2028), X090516009(16/01/2029); ILM 4013N/7899995274106/W080449448(16/08/2027), X120531842(17/12/2028), X120530728(17/12/2028), X120530726(17/01/2029), X120530724(16/12/2028), X120530730(17/12/2028), Y010537900(17/12/2028), W090454924(16/09/2028), X010473946(16/12/2028), W100458876(16/09/2028), X120531618(17/12/2028), X090517847(16/12/2028), X120530300(16/12/2028), X120531930(17/12/2028), X010472967(16/12/2028), X090517840(16/12/2028), X090515626(16/12/2028), X090515638(16/12/2028); ILM 4020N/7899995273499/X120530786(17/12/2028); ILM 4085N/7899995274144/X120531822(18/06/2028); ILM 4513N/7899995274038/X120530720(20/03/2028), Y010538078(22/09/2028), X120530722(20/10/2027), X120530849(22/06/2028); ILM 4515N/7899995274021/X120530902(23/10/2028), X120530716(23/07/2028), X120530340(23/03/2028); ILM 4585N/7899995274076/X110529195(25/11/2028), X110529193(25/10/2027); ILM 5010N/7899995273970/X040490644(26/12/2028), X040490886(26/12/2028); ILM 5011N/7899995273963/X120530851(26/12/2028); ILM 4510N/7899995274069/Y010537208(18/12/2028); ILM 5013N/7899995273956/X100522628(27/06/2027); ILM 5015N/7899995273932/X120530844(28/12/2028), X040490872(27/12/2028); ILM 5085N/7899995274007/X120530511(28/12/2028), X120530714(29/01/2029), X120530338(28/12/2028), Y010536031(30/05/2028); ILM 4018N/7899995273529/Y010537853(17/12/2028); ILM 3818N/7899995280886/Y010536867(13/12/2028); ILM 4511N/7899995274045/X120531860(18/12/2028), X120531935(18/12/2028), X120530732(18/12/2028); ILM 4515/7899995280169/X060497920(23/02/2028), X060497915(23/01/2028); ILM 4585/7899995280251/X040490690(24/01/2028), X120529433(24/01/2029), X120529450(24/01/2029); ILM 3813/7899995280527/Y020539359(6/2/2029); ILM 3815/7899995280473/Y010535029(7/2/2029); ILM 5085/7899995280091/X090516829(28/12/2028); ILM 3811/7899995280534/X110528601(10/10/2028); ILM 3820N/7899995273642/V110406210(13/12/2028), X020479077(X020479077); ILM 4518N/7899995273437/W060438138(24/01/2028), X120531278(24/01/2028); UCMC 6007N/7899995215895/Y010536358(30/10/2028);

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0017-2026