Epikut Plus Dental Implant (S.I.N. Implant) – storage conditions (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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,
Brand
S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil
Lot Codes / Batch 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)
Products Sold
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);
S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil is recalling IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3 due to Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 7/30/2025, correction notices were emailed to customers who were asked to do the following: 1) Return affected devices 2) Complete and return the response form via email to sbassett@sindentalusa.com 3) Disseminate the notice to staff and to other services or facilities, as applicable.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026