Miach Orthopaedics, Inc.
Active in EUDAMEDUnited Statesfrom EUDAMED address EUDAMED SRN US-MF-000046969
- Devices
- 4
- Registrations
- EUDAMED
- FDA recalls
- 22 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
Catalogue
- Registry: GUDID
BEAR® (Bridge-Enhanced ACL Restoration) Implant Ref K243578
Regimes: 510(k) Registry: 510(k)BEAR (Bridge-Enhanced ACL Repair) Implant Ref DEN200035
Regimes: De Novo Registry: De NovoBEAR® (Bridge-Enhanced ACL Restoration) Implant Ref K251214
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000046969
- DUNS number
- 016027522
- EUDAMED status
- Active
- EUDAMED registered name
- Miach Orthopaedics, Inc.
- [email protected]
- PRRC contact
- Rita Paparazzo
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 1
- 2026 0
2025
- 31 Dec 2025 Z-1220-2026 Class II Ongoing Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Full distribution text
- 31 Dec 2025 Z-1220-2026 Class II Ongoing Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
2023
- 2 Feb 2023 Z-0479-2026 Class II Ongoing The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Frequently asked questions
How many devices does Miach Orthopaedics, Inc. have in the registry?
The registry currently lists 4 devices for Miach Orthopaedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Miach Orthopaedics, Inc.'s devices?
Among its 4 most recently registered devices, Miach Orthopaedics, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Miach Orthopaedics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Miach Orthopaedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Miach Orthopaedics, Inc.?
FDA recall records list 2 recalls initiated by Miach Orthopaedics, Inc., the most recent initiated on 31 Dec 2025. 2 of them are recorded as ongoing. 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 Miach Orthopaedics, Inc. in the registry?
The most recently registered devices listed for Miach Orthopaedics, Inc. include BEAR Implant (Bridge-Enhanced ACL Restoration) 1000, BEAR® (Bridge-Enhanced ACL Restoration) Implant and BEAR (Bridge-Enhanced ACL Repair) Implant.