Recall Z-0573-2011 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Zimmer Inc.
TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-020-00. The intramedullary reamer is used to open the mid to distal humeral canal to accept the implant.
| Date | Dec 9, 2010 (initiated Sep 10, 2010) |
| Status | Terminated |
| Reason | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application. |
| Root cause | Device Design |
| Action | Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to: a. provide the Dear Surgeon (Urgent Device Correction) letter and revised surgical technique directly to surgeons and risk managers at facilities using the device or b. provide a list of facilities and surgeons using the TM Humeral and TM Reverse shoulder systems to the Zimmer Recall Coordinator, and c. destroy previous versions of the surgical techniq |
| Quantity | 13,093 total reamers in distribution. |
| Distribution | Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041549 | ZIMMER TRABECULAR METAL HUMERAL STEM Zimmer, Inc., Sep 1, 2004 |
| K050761 | ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM Zimmer, Inc., Apr 11, 2005 |
| K052906 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM Zimmer, Inc., Dec 19, 2005 |
| K060704 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM Zimmer, Inc., May 19, 2006 |