Recall Z-1012-2018 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
DePuy Orthopaedics, Inc.
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO-110030100_REV D.pdf.pdf, LEO-110030110_REV D.pdf.pdf, LEO-110030120_REV D.pdf.pdf
| Date | Feb 27, 2018 (initiated Nov 28, 2017) |
| Status | Terminated |
| Reason | The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays. |
| Root cause | Employee error |
| Action | DePuy Orthopaedics, Inc. is voluntarily recalling 11 lots of the GLOBAL UNITE Platform Shoulder System. The device is being recalled because the screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays. Once the screw is properly assembled, there is no additional risk to the patient. Further distribution or use of the affected lots is to cease immediately.DePuy Orthopaedics, Inc. is not recommending prophylactic revision. The company recommends t |
| Quantity | 85 |
| Distribution | Distribution Level: The device removal is extended to the companies US Distributors/Sales Offices and Medical Facilities that may have used, purchased, or received the affected devices. Approximately 53 units distributed to firm's international affiliates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM Depuy(Ireland), Apr 3, 2014 |