Hand Biomechanics Lab
Active in EUDAMEDUnited Statesfrom EUDAMED address EUDAMED FDA SRN US-MF-000057112
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment, FDA recalls
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
Company details
- EUDAMED SRN
- US-MF-000057112
- EUDAMED status
- Active
- EUDAMED registered name
- Hand Biomechanics Lab
- [email protected]
- PRRC contact
- Egypt Brown
FDA recalls
2016
- 14 Sep 2016 Z-0136-2017 Class II Terminated A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device.
FDA establishments
- Hand Biomechanics Lab, Inc. SACRAMENTO, CA · US FEI 2919128
Frequently asked questions
How many devices does Hand Biomechanics Lab have in the registry?
The registry currently lists 6 devices for Hand Biomechanics Lab. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hand Biomechanics Lab's devices?
Among its 6 most recently registered devices, Hand Biomechanics Lab has devices listed in FDA GUDID (6 devices).
What risk classes do Hand Biomechanics Lab's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Hand Biomechanics Lab's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Hand Biomechanics Lab?
FDA recall records list 1 recall initiated by Hand Biomechanics Lab, the most recent initiated on 2016-09-14. 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 Hand Biomechanics Lab in the registry?
The most recently registered devices listed for Hand Biomechanics Lab include Agee TurnKey FCS® FCS-400, Agee WristJack® Remanufactured CFD-147-RNS, Agee Digit Widget® DWD-232 and PIP Fix PFX-426.
Which FDA establishments are linked to Hand Biomechanics Lab?
1 FDA establishment is linked to Hand Biomechanics Lab in the registry; they are listed on the company page.