Z-1111-2015 Class II Terminated
FDA device recall Z-1111-2015 was initiated by Arthrosurface, Inc. on November 24, 2014 and is designated Class II. Reason for recall: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. The recall status is terminated (terminated March 27, 2015). Affected quantity: 143.
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
- 143
Product Description
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. 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: 6125-0035, Part Number: 1125-0035