Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 22, 2025
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the…
Sin Sistema De Implante Nacional S.a recalled Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N - a moderate-severity action.
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N was recalled by Sin Sistema De Implante Nacional S.a in January 22, 2025. Reason: Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels …. Check the official notice for the remedy. Verify recall #Z-0920-2025 with the FDA Devices before acting.
The recall
Sin Sistema De Implante Nacional S.a issued this moderate-severity FDA Devices recall-Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels ….
- Moderate
- severity level
- Class II
- classification
- January 22, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0920-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0920-2025) was formally reported on January 22, 2025, with the manufacturer initiating the action on September 1, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Sin Sistema De Implante Nacional S.a is listed as the recalling firm, operating out of Sao Paulo. Federal records list the affected scope as 123 (US 98, OUS 25).
The documented reason for this recall is: Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the … Distribution data in the federal record shows the product reached: US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
123 (US 98, OUS 25)
Related Recalls
6
3 from same agency
Product description
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Reason for recall
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0920-2025 |
| Date reported | January 22, 2025 |
| Date initiated | September 1, 2024 |
| Recalling firm | Sin Sistema De Implante Nacional S.a |
| Firm location | Sao Paulo |
| Affected scope | 123 (US 98, OUS 25) |
| Distribution | US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0920-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N. Recalled by Sin Sistema De Implante Nacional S.a. Units affected: 123 (US 98, OUS 25).
Why was this product recalled? ▼
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0920-2025.
Where was the recalled product distributed? ▼
Distribution: US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0920-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 22, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.