Implant Epikut Plus Mt16 3,5x10,0mm, Ref: Ilm 3510n recallZ-0017-2026 · S.I.N. Implant System Ltda · initiated Jul 30, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from S.I.N. Implant System Ltda or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Environmental control
What the company 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 [email protected] 3) Disseminate the notice to staff and to other services or facilities, as applicable.
Recall details
- Recall number
- Z-0017-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 30, 2025
- Posted by the FDA
- Oct 1, 2025
- Recalling firm
- S.I.N. Implant System Ltda
- Quantity
- 6,360
- Product code
- DZE
- Distribution
- 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.
Product 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
Code information (models, lots, serial numbers)
Show the full code information (3k characters)
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);
Devices named in this recall
33 devices in the FDA device registry whose identifier appears in the recall's code information.
- IMP. EPIKUT PLUS MT16° Ø4,5X18,0MM ILM 4518NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form2 recalls0 reports
- Unitite UCMC 6007NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,0X20,0MM ILM 4020NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,0X18,0MM ILM 4018NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø3,8X20,0MM ILM 3820NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø5,0X15,0MM ILM 5015NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø5,0X13,0MM ILM 5013NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø5,0X11,5MM ILM 5011NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø5,0X10,0MM ILM 5010NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø5,0X8,5MM ILM 5085NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,5X15,0MM ILM 4515NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,5X13,0MM ILM 4513NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM ILM 4585NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,5X10,0MM ILM 4510NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM ILM 4585NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,0X13,0MM ILM 4013NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,0X11,5MM ILM 4011NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,0X10,0MM ILM 4010NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,0X8,5MM ILM 4085NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø3,8X15,0MM ILM 3815NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø3,8X11,5MM ILM 3811NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø3,8X10,0MM ILM 3810NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø3,5X13,0MM ILM 3513NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø3,5X11,5MM ILM 3511NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø3,5X10,0MM ILM 3510NSin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT MT16° Ø5,0X8,5MM ILM 5085Sin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT MT16° Ø4,5X15,0MM ILM 4515Sin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT MT16° Ø4,5X8,5MM ILM 4585Sin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT MT16° Ø3,8X15,0MM ILM 3815Sin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT MT16° Ø3,8X13,0MM ILM 3813Sin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT MT16° Ø3,8X11,5MM ILM 3811Sin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT MT16° Ø3,8X18,0MM ILM 3818Sin Sistema de Implante Nacional S/A · Implant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT MT16° Ø3,5X15,0MM ILM 3515Sin Sistema de Implante Nacional S/A · Prosthesis, Nose, Internal1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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