| 2026-08-12 |
Class II
|
Ongoing |
Z-3173-2026 |
GM Helix Implant, REF: 109.984; |
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There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. |
| 2026-07-16 |
Class II
|
Ongoing |
Z-2935-2026 |
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endos… |
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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 la… |
| 2026-07-13 |
Class II
|
Ongoing |
Z-2929-2026 |
GM Helix Implant, Endosseous Dental Implant Article No. 109.984 |
— |
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant… |
| 2026-03-27 |
Class II
|
Ongoing |
Z-1995-2026 |
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments |
— |
Includes an incorrect screw seat interface. |
| 2026-03-27 |
Class II
|
Ongoing |
Z-1994-2026 |
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutmen… |
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Includes an incorrect screw seat interface. |
| 2026-03-17 |
Class II
|
Ongoing |
Z-1633-2026 |
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; |
— |
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot… |
| 2026-03-17 |
Class II
|
Ongoing |
Z-1632-2026 |
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; |
— |
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot… |
| 2026-01-06 |
Class III
|
Ongoing |
Z-1337-2026 |
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM |
— |
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. |
| 2025-10-17 |
Class II
|
Ongoing |
Z-0582-2026 |
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; |
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The possibility for this product that is intended for demonstration purposes only to be placed in patients. |
| 2025-05-01 |
Class II
|
Ongoing |
Z-1863-2025 |
GM Helix Acqua Implant, Article Number: 140.985 |
— |
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. |
| 2025-05-01 |
Class II
|
Ongoing |
Z-1862-2025 |
GM Helix Acqua Implant, Article Number: 140.984 |
— |
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. |
| 2025-04-17 |
Class II
|
Ongoing |
Z-1671-2025 |
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. |
— |
Incorrect blister labelling. |
| 2025-04-14 |
Class II
|
Ongoing |
Z-1861-2025 |
Plus Initial Drill, Article Number: 103.170; |
— |
The referred batch was produced without the laser engraving of 7 mm. |
| 2025-03-08 |
Class II
|
Ongoing |
Z-1561-2025 |
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; |
— |
The devices are missing the laser marked depth markings. |
| 2021-11-30 |
Class II
|
Terminated |
Z-0513-2022 |
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 |
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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 Heli… |
| 2021-11-30 |
Class II
|
Terminated |
Z-0512-2022 |
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089 |
— |
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 Heli… |
| 2021-06-25 |
Class II
|
Ongoing |
Z-2336-2021 |
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards… |
— |
Product label intended for the European community was distributed to the USA market via their US distribution organization |
| 2021-05-27 |
Class II
|
Terminated |
Z-2198-2021 |
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgica… |
— |
Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick… |