Arthrosurface Recalls
6 recalls on record · February 18, 2015 to December 30, 2015 · Medical Devices
December 30, 2015Medical DevicesFDA
Arthrosurface, Inc. recalls Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 Th
Hazard: An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
February 18, 2015Medical DevicesFDA
Arthrosurface, Inc. recalls Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. Hem
Hazard: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
February 18, 2015Medical DevicesFDA
Arthrosurface, Inc. recalls Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP
Hazard: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
February 18, 2015Medical DevicesFDA
Arthrosurface, Inc. recalls Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP
Hazard: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
February 18, 2015Medical DevicesFDA
Arthrosurface, Inc. recalls Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiC
Hazard: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
February 18, 2015Medical DevicesFDA
Arthrosurface, Inc. recalls Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCA
Hazard: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.