Recall Z-2003-2016 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Zimmer Gmbh
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is inte
| Date | May 17, 2016 |
| Status | Terminated |
| Reason | In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary. |
| Root cause | Device Design |
| Action | Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notification dated May 17, 2016, to all affected consignees via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Consignees were instructed to review the notification and ensure affected personnel were aware of the contents. Assist their Zimmer Bioment sales representative with the quarantine of any affected pro |
| Quantity | 177 |
| Distribution | Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142403 | Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System Zimmer GmbH, Nov 24, 2014 |