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RecallWatchMedical Device Safety
Class IIOngoingZ-0017-2026

S.I.N. Implant System Ltda recalls IMPLANT EPIKUT PLUS MT16 3

S.I.N. Implant System LtdaSao Paulo, BrazilReported Oct 8, 2025 · 9 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

IMPLANT EPIKUT PLUS MT16 3,5X10,0MM1 code
  • ILM 3510N
IMPLANT EPIKUT PLUS MT16 3.8X11.5MM1 code
  • ILM 3511N
IMPLANT EPIKUT PLUS MT16 3,5X13,0MM1 code
  • ILM 3513N
IMPLANT EPIKUT PLUS MT16 3,5X15,0MM1 code
  • ILM 3515N
IMPLANT EPIKUT PLUS MT16 3,8X10,0MM1 code
  • ILM 3810N
IMPLANT CM16 3,8 X 11MM1 code
  • ILM 3811N
IMPLANT EPIKUT PLUS MT16 3,8X15,0MM1 code
  • ILM 3815N
IMPLANT EPIKUT PLUS MT16 4,0X10,0MM1 code
  • ILM 4010N
IMPLANT EPIKUT PLUS MT16 4,0X11,5MM1 code
  • ILM 4011N
IMPLANT EPIKUT PLUS MT16 4,0X13,0MM1 code
  • 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 4,5X13,0MM1 code
  • ILM 4513N
IMPLANT EPIKUT PLUS MT16 4,5X15,0MM1 code
  • ILM 4515N
IMPLANT EPIKUT PLUS MT16 4,5X8,5MM1 code
  • ILM 4585N
IMPLANT EPIKUT PLUS MT16 5,0X10,0MM1 code
  • ILM 5010N
IMPLANT EPIKUT PLUS MT16 5,0X11,5MM1 code
  • ILM 5011N
IMPLANT EPIKUT PLUS MT16 4,5X10,0MM1 code
  • ILM 4510N

IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N

IMPLANT EPIKUT PLUS MT16 5,0X15,0MM1 code
  • ILM 5015N
IMPLANT EPIKUT PLUS MT16 5,0X8,5MM1 code
  • ILM 5085N
IMP EPIKUT PLUS LONG MT16 4,0X18,0MM1 code
  • ILM 4018N
IMP EPIKUT PLUS LONG MT16 3,8X18,0MM1 code
  • ILM 3818N
IMPLANT EPIKUT PLUS MT16 4,5X11,5MM1 code
  • ILM 4511N
IMPLANT EPIKUT MT16 4,5X15,0MM1 code
  • ILM 4515
IMPLANT EPIKUT MT16 4,5X8,5MM1 code
  • ILM 4585
IMPLANT EPIKUT MT16 3,8X13,0MM1 code
  • ILM 3813
IMPLANT EPIKUT MT16 3,8X15,0MM1 code
  • ILM 3815
IMPLANT EPIKUT MT16 5,0X8,5MM1 code
  • ILM 5085
IMPLANT EPIKUT MT16 3,8X11,5MM1 code
  • ILM 3811
IMPLANT EPIKUT PLUS MT16 3,8X20,0MM1 code
  • ILM 3820N
IMPLANT EPIKUT PLUS MT16 4,5X18,0MM1 code
  • ILM 4518N
IMPLANT UNITITE MORSE COMPACT 6.0X7MM1 code
  • UCMC 6007N

Lot / code information

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) — +66 moreShow all
(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)

What the firm is doing

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.

DistributionShow details

US Nationwide distribution including in the states of TX, IL, KY, NC, TN, CO, CA, MO, MD, AL, FL, PA, UT, NE, ID, AZ, WA, OK, OR, NV, NJ, VA, NY, LA, CT, SD, SC, HI, KS, MA, MI, NM, OH, MT, WI, MN, ME.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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