Device product
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Z-1112-2015
Product summary
- Event
- Event 69723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 138
- Official record key
device-enforcement:Z-1112-2015
Official wording
Reason: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Code information: Catalog Number: 8135-0032, Part Number: 3135-0032
Distribution pattern: Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Derived failure modes
-
Unknown
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.