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.
This recall has been terminated (originally issued February 12, 2015).
- Company
- Arthrosurface, Inc.
- Recall Initiated
- November 24, 2014
- Posted
- February 12, 2015
- Terminated
- March 27, 2015
- Recall Number
- Z-1111-2015
- Quantity
- 143
- Firm Location
- Franklin, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Lot / Code Info
Catalog Number: 6125-0035, Part Number: 1125-0035
Root Cause
No Marketing Application
Action Taken
Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.