Home / Recalls / Arthrosurface, Inc. / Z-1113-2015

Z-1113-2015 Class II Terminated

Recalled by Arthrosurface, Inc. — Franklin, MA

Recall Details

Product Type
Devices
Report Date
February 18, 2015
Initiation Date
November 24, 2014
Termination Date
March 27, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
182 units

Product Description

Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.

Reason for Recall

Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.

Distribution Pattern

Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.

Code Information

Catalog Number: 8135-1875 Part Number: 3135-1875

Other recalls by Arthrosurface, Inc.

  • Z-1112-2015 Class II — Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135 (November 24, 2014)
  • Z-1114-2015 Class II — Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number (November 24, 2014)
  • Z-1110-2015 Class II — Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6 (November 24, 2014)
  • Z-1111-2015 Class II — Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6 (November 24, 2014)
  • Z-0475-2016 Class II — Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Fla (June 9, 2014)