FDA Device recall Z-0920-2025
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N by Sin Sistema De Implante Nacional, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0920-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-01 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sin Sistema De Implante Nacional |
| Distribution | CA, CO, FL, ID, IL, KY, NJ, NY, OH, TX |
Product
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Reason
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.
Identifiers
| code_info | UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0920-2025%22
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