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Magicore S
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) · Model 454M5008S · UDI-DI 08800039399951
DZE
Prescription
1
510(k) clearances
3,224,994
Adverse events (44 deaths)
211
Recalls
327
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-16 | Straumann USA LLC | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest |
| 2025-07-30 | S.I.N. Implant System Ltda | 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 |
| 2025-05-01 | Straumann USA LLC | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. |
| 2025-05-01 | Straumann USA LLC | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. |
| 2025-01-10 | Nobel Biocare | Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the fin |
| 2024-09-01 | SIN SISTEMA DE IMPLANTE NACIONAL S.A | 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 |
| 2023-04-06 | Hiossen Inc. | Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm |
| 2022-07-25 | Nobel Biocare | Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. |
| 2021-12-17 | Nobel Biocare Usa Llc | Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the |
| 2021-11-30 | Straumann USA LLC | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.