Plan Les Ouates, CH · 12 510(k) clearances · 5 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 5 | 2026-07-29 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | 2 | 2026-05-01 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | Class II | Orthopedic | 1 | 2026-08-14 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2024-10-23 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 1 | 2024-07-18 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2024-05-10 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | 1 | 2023-03-22 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-06-30 | Class II | Ongoing | Z-2280-2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S … | — | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2025-06-30 | Class II | Ongoing | Z-2279-2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S … | — | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2024-03-15 | Class II | Ongoing | Z-1758-2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-… | — | Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tight… |
| 2023-03-16 | Class II | Ongoing | Z-1426-2023 | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, J… | — | JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or dur… |
| 2021-04-09 | Class II | Terminated | Z-1975-2021 | PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle … | — | Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-14 | K262639 | BAGUERA® C Cervical Disc Surgical Instruments | QLQ | Class II | Orthopedic |
| 2026-07-29 | K261205 | SPINEART Navigation Instrument System | OLO | Class II | Neurology |
| 2026-05-01 | K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | NKB | Class II | Orthopedic |
| 2026-04-09 | K254158 | SPINEART Navigation Instrument System | OLO | Class II | Neurology |
| 2025-06-18 | K242933 | SPINEART Navigation Instrument System | OLO | Class II | Neurology |
| 2025-03-07 | K242890 | SPINEART Navigation Instrument System | OLO | Class II | Neurology |
| 2024-10-23 | K242589 | Scarlet® AL-T | MAX | Class II | Orthopedic |
| 2024-08-07 | K241644 | SPINEART Navigation Instrument System | OLO | Class II | Neurology |
| 2024-07-18 | K241321 | Juliet® Ti LL Lumbar Interbody Device | OVD | Class II | Orthopedic |
| 2024-05-10 | K240699 | SCARLET® AC-Ti | OVE | Class II | Orthopedic |
| 2023-10-25 | K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | NKB | Class II | Orthopedic |
| 2023-03-22 | K230583 | Tryptik Ti | ODP | Class II | Orthopedic |