FDAFDA · Food and drugs·Recall number Z-1114-2015
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Published February 18, 2015 · Recall initiated: November 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arthrosurface, Inc.
- Distributor
- Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
- Lot
- Catalog Number: 8156-0032, Part Number: 156-0032
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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