Reported Oct 8, 2025 · Ongoing

IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT…

S.I.N. Implant System Ltda

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: S.I.N. Implant System Ltda · Rua Soldador Ocimar Guimaraes da Silva 421 · Sao Paulo, N/A · N/A

Is this the product you have?

33 of 33 products

Products covered by this recall
#Product as published
1IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N
2IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N
3IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N
4IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N
5IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N
6IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N
7IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N
8IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N
9IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N
10IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N
11IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N
12IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N
13IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N
14IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N
15IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N
16IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N
17IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N
18IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N
19IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N
20IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N
Lot codes and dates

33 of 33 products

Products covered by this recall
#BarcodesProduct as published
17899995277558ILM 3510N/7899995277558/X010469795(9/12/2026)
27899995274342ILM 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)
37899995274335ILM 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)
47899995280893ILM 3515N/7899995280893/W020420816(6/12/2028), X030484303(10/2/2028), X010472646(9/12/2028), X010472644(8/10/2028), X120531182(10/5/2028)
57899995274274ILM 3810N/7899995274274/X120531775(10/5/2028)
67899995274229ILM 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)
77899995274168ILM 3815N/7899995274168/X120531820(11/2/2029), X120531267(11/2/2029), X010473617(11/2/2029), V110406564(10/2/2029)
87899995274137ILM 4010N/7899995274137/Y020538716(14/12/2028), X120530744(14/12/2028), X120530266(14/01/2029)
97899995274113ILM 4011N/7899995274113/W100458406(15/12/2028), V110406330(15/12/2028), X120531292(16/05/2028), V110404633(15/12/2028), X090516009(16/01/2029)
107899995274106ILM 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)
117899995273499ILM 4020N/7899995273499/X120530786(17/12/2028)
127899995274144ILM 4085N/7899995274144/X120531822(18/06/2028)
137899995274038ILM 4513N/7899995274038/X120530720(20/03/2028), Y010538078(22/09/2028), X120530722(20/10/2027), X120530849(22/06/2028)
147899995274021ILM 4515N/7899995274021/X120530902(23/10/2028), X120530716(23/07/2028), X120530340(23/03/2028)
157899995274076ILM 4585N/7899995274076/X110529195(25/11/2028), X110529193(25/10/2027)
167899995273970ILM 5010N/7899995273970/X040490644(26/12/2028), X040490886(26/12/2028)
177899995273963ILM 5011N/7899995273963/X120530851(26/12/2028)
187899995274069ILM 4510N/7899995274069/Y010537208(18/12/2028)
197899995273956ILM 5013N/7899995273956/X100522628(27/06/2027)
207899995273932ILM 5015N/7899995273932/X120530844(28/12/2028), X040490872(27/12/2028)
Amount recalled
6,360

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new S.I.N. Implant System Ltda recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

By hazard

Where it was distributed

All recall categories · Browse the whole archive

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.