Z-0017-2026Class II

Implant Epikut Plus Mt16 3,5X10,0mm, Ref: Ilm 3510N; Implant Epikut Plus Mt16 3.8X11.5mm, Ref: Ilm 3511N...

Name: Z-0017-2026 Implant Epikut Plus Mt16 3,5X10,0mm, Ref: Ilm 3510N; Implant Epikut Plus Mt16 3.8X11.5mm, Ref: Ilm 3511N...
Creator: S.I.N. Implant System Ltda
Published: 2025-07-30
License: https://open.fda.gov/license/

S.I.N. Implant System Ltda / initiated 2025-07-30 / Open, Classified / root cause: manufacturing process

FDA source

S.I.N. Implant System Ltda began a recall of 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... on 2025-07-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0017-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-30
Posted: 2025-10-01
Recalling firm: S.I.N. Implant System Ltda
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 4,0X13,0mm, 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 code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: 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.
Quantity in commerce: 4,367
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 codes and lots: 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);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0017-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0017-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-01

Product code DZE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)