Device product
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.
Z-1111-2015
Product summary
- Event
- Event 69723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 143
- Official record key
device-enforcement:Z-1111-2015
Official wording
Reason: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Code information: Catalog Number: 6125-0035, Part Number: 1125-0035
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.