Recall Z-1079-2014 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Zimmer, Inc.
Trabecular Metal" Reverse Shoulder System
| Date | Feb 24, 2014 (initiated Oct 17, 2013) |
| Status | Terminated |
| Reason | As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate. |
| Root cause | Device Design |
| Action | In November and December 2012 Sales staff were provided updated surgical technique and associated video to share with current customers, surgeons, and risk managers. October 17, 2013 Distributors ( via E-mail),and Risk Managers and Surgeons (via traceable courier) were sent written Urgent Recall notifications of these labeling changes. Current customers are identified through an invoice search and distribution history for the affected devices for the past 12 months, since 9/1/12. |
| Quantity | 73,002 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052906 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM Zimmer, Inc., Dec 19, 2005 |