Merete Medical GmbH
Country not established
- Devices
- 25
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Merete Medical GmbH makes
Merete Medical GmbH manufactures orthopedic fixation devices, including bone screws (such as TwistCut and EndoSorb variants), locking and compression plates, and intramedullary rods for knee arthrodesis and diaphyseal defect fixation. Their portfolio also includes ceramic hip inlay components, subtalar stabilization implants, and cortical screws for bone stabilization.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class II and Unclassified (U). These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 25 devicesFDA recalls
FDA recall records list 5 recalls initiated by Merete Medical GmbH, the earliest on 2020-09-18 and the most recent on 2022-01-18. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 4
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 18 Jan 2022 Z-0650-2022 Class II Terminated Incorrect marketing label (25 mm) was applied to product size 20 mm.
2020
- 18 Sep 2020 Z-0435-2021 Class II Terminated Product may be mislabeled.
- 18 Sep 2020 Z-0436-2021 Class II Terminated Product may be mislabeled.
- 18 Sep 2020 Z-0437-2021 Class II Terminated Product may be mislabeled.
- 18 Sep 2020 Z-0438-2021 Class II Terminated Product may be mislabeled.
Frequently asked questions
How many devices does Merete Medical GmbH have in the registry?
The registry currently lists 25 devices for Merete Medical GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Merete Medical GmbH's devices?
Among its 25 most recently registered devices, Merete Medical GmbH has devices listed in FDA 510(k) (25 devices).
What risk classes do Merete Medical GmbH's devices fall under?
Among its 25 most recently registered devices, the classes recorded for Merete Medical GmbH's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Merete Medical GmbH?
FDA recall records list 5 recalls initiated by Merete Medical GmbH, the most recent initiated on 18 Jan 2022. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Merete Medical GmbH in the registry?
The most recently registered devices listed for Merete Medical GmbH include MERETE TWISTCUT SNAP-OFF BONE SCREW, BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD, METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31, RIGHT and MERETE LOCKING BONE PLATE SYSTEM III.