Recall Z-1110-2015 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Arthrosurface, Inc.
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
| Date | Feb 12, 2015 (initiated Nov 24, 2014) |
| Status | Terminated |
| Reason | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 136 |
| Distribution | Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023096 | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM Std Mfg., Inc., Apr 10, 2003 |