| | Class 2 Device Recall IMPLANT EPIKUT PLUS |  |
| Date Initiated by Firm | July 30, 2025 |
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| Date Posted | October 01, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0017-2026 |
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| Recall Event ID |
97553 |
| Product Classification |
Implant, endosseous, root-form - Product Code DZE
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| 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 |
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| Code Information |
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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Recalling Firm/
Manufacturer |
S.I.N. Implant System Ltda
Rua Soldador Ocimar Guimaraes da Silva 421
Jardim Analia Franco
Sao Paulo Brazil
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| For Additional Information Contact |
55 11 66941070 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Environmental control |
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| 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 sbassett@sindentalusa.com
3) Disseminate the notice to staff and to other services or facilities, as applicable.
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| Quantity in Commerce | 4,367 |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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