Recall Z-2414-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 7 sterile, REF 00-5950-057-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-trauma
| Date | Sep 13, 2010 (initiated Apr 26, 2010) |
| Status | Terminated |
| Reason | The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required additional surgery to replace the device. |
| Root cause | Other |
| Action | The firm, Zimmer, Inc., sent an "URGENT DEVICE CORRECTION" letter dated April 26, 2010, to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to destroy or disregard all previous versions of the surgical technique, review the attached revised surgical technique to familiarize yourself with the modifications and warnings, and complete and return the Health Care Professional Dcoumentation Form via fax to Zimmer, Inc. at (574) 372-4265. (Note: Zimmer made a modification to the surgical technique and instructions for use. Th |
| Quantity | 68,384 all products |
| Distribution | Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043101 | NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS Zimmer, Inc., Mar 7, 2005 |