FDA Device Recall Z-0017-2026: S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0017-2026.

Recall Res Number

Z-0017-2026

Recalling Firm / Manufacturer

S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil

FEI Number

3004201263

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2025-07-30

Date Posted

2025-10-01

Date Terminated

N/A

Product Code

DZE

Event Number

97553

Product Quantity

4,367

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

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.

Action Details 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.

Distribution Pattern 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.

Code Information / Serial 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);

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UNIDENTAL.CO.KR Registration: 3029973218 View Registration
DMI TECHNOLOGY LLC Registration: 3030039110 View Registration
MegaGen Implant Co., Ltd. (Research Laboratories) Registration: 3030089802 View Registration
PHARMCO MEDICAL BV Registration: 3030447506 View Registration
TRATE LLC Registration: 3030690317 View Registration
HIGHNESS CO.,LTD. Registration: 3031462380 View Registration
IZENIMPLANT CO., LTD. Registration: 3031493119 View Registration
TRATE UAB Registration: 3031529635 View Registration
MOZO-GRAU SA Registration: 3031553803 View Registration
OSSTEM IMPLANT CO., LTD. Registration: 3031886796 View Registration
Solventum US LLC Registration: 3032163716 View Registration
ZEROS CO., LTD. Registration: 3032439351 View Registration
8dent Inc. Registration: 3033519161 View Registration
RDJ TOV IMPLANT LTD Registration: 3033524692 View Registration
PARAGON IMPLANT COMPANY, LLC Registration: 3033708818 View Registration
Straumann Manufacturing, Inc. Registration: 3033781108 View Registration
BASIC (CHENGDU) MEDICAL DEVICE CO., LTD. Registration: 3035820532 View Registration
Dentis Co.,Ltd Registration: 3036190511 View Registration
QUICKDENT DEVICES PRIVATE LIMITED Registration: 3036779616 View Registration
LX PRECISION PORTUGAL, UNIPESSOAL, LDA Registration: 3038136479 View Registration
INFINETAMED AG Registration: 3038549074 View Registration
NUVENTUS B.V. Registration: 3040978916 View Registration
AMG DENTAL LTD Registration: 3042227762 View Registration
SOLVENTUM US LLC Registration: 3042272797 View Registration
DIMPLO Ltd. Registration: 3042971970 View Registration
SURCAM MEDICAL DEVICES AND DEVELOPMENTS LTD Registration: 3043585140 View Registration
MEDICON, E.G. Registration: 8010099 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
GEBR. BRASSELER GMBH & CO. KG Registration: 8010468 View Registration
HAGER & MEISINGER GMBH Registration: 8010516 View Registration
Faulhaber Pinzetten KG Registration: 8010591 View Registration
ANTHOGYR Registration: 8020776 View Registration
DENTATUS AB Registration: 8030870 View Registration
CENDRES+METAUX SA Registration: 8031058 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
T.A.G. MEDICAL PRODUCTS CORPORATION LTD Registration: 8043971 View Registration
WESLEY COE (CAMBRIDGE) LTD Registration: 8044131 View Registration
KLS Martin SE & Co. KG Registration: 9610905 View Registration
NAKANISHI INC. Registration: 9611253 View Registration
NOBEL BIOCARE AB Registration: 9611992 View Registration
NOBEL BIOCARE AB, PRODUKTION Registration: 9611993 View Registration
GC CORP. Registration: 9612300 View Registration
Dentsply IH AB Registration: 9612468 View Registration
HI TEC IMPLANTS, LTD. Registration: 9613283 View Registration
INSTITUT STRAUMANN AG Registration: 9613348 View Registration
MEDISCAN GMBH & CO. KG Registration: 9613662 View Registration
ALTATEC GMBH Registration: 9613866 View Registration
Straumann Villeret SA Registration: 9614404 View Registration
TECHNOVENT LIMITED Registration: 9617078 View Registration
SOADCO, S.L. Registration: 9617542 View Registration
JOSEF GANTER FEINMECHANIK GMBH Registration: 9680605 View Registration
RHEIN 83 SRL Registration: 9680939 View Registration
ODONTIT SA Registration: 9680963 View Registration
Sirona Dental Systems GmbH Registration: 9681851 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0017-2026

Recall Parameters & Description

Related Establishments / Registrations

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