Arthrosurface, Inc.
United StatesFDA applicant, unverified FDA FEI 3004154314
- Devices
- 26
- Registrations
- FDA
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 26 devicesCompany details
- FDA FEI number
- 3004154314
- Address
- 319 Manley St, W Bridgewater, MA, 02379
FDA recalls
2014
- 24 Nov 2014 Z-1110-2015 Class II Terminated Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Full distribution text
- 24 Nov 2014 Z-1111-2015 Class II Terminated Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Full distribution text
- 24 Nov 2014 Z-1112-2015 Class II Terminated Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Full distribution text
- 24 Nov 2014 Z-1113-2015 Class II Terminated Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Full distribution text
- 24 Nov 2014 Z-1114-2015 Class II Terminated Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Full distribution text
- 9 Jun 2014 Z-0475-2016 Class II Terminated An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
- 24 Nov 2014 Z-1110-2015 Class II Terminated Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Frequently asked questions
How many devices does Arthrosurface, Inc. have in the registry?
The registry currently lists 26 devices for Arthrosurface, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arthrosurface, Inc.'s devices?
Among its 26 most recently registered devices, Arthrosurface, Inc. has devices listed in FDA 510(k) (26 devices).
What risk classes do Arthrosurface, Inc.'s devices fall under?
Among its 26 most recently registered devices, the classes recorded for Arthrosurface, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Arthrosurface, Inc.?
FDA recall records list 6 recalls initiated by Arthrosurface, Inc., the most recent initiated on 24 Nov 2014. 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 Arthrosurface, Inc. in the registry?
The most recently registered devices listed for Arthrosurface, Inc. include Wrist Hemiarthroplasty System, Patello-Femoral Wave (Kahuna) Arthroplasty System, HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS and CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY.