Recall Z-0609-2011 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.
| Date | Dec 13, 2010 (initiated Apr 16, 2010) |
| Status | Terminated |
| Reason | The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications may also require revision surgery. |
| Root cause | Device Design |
| Action | Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices. Customers can contact ZImmer, Inc. at 800 613-6131 concerning this recall. |
| Quantity | 10,666 all products. |
| Distribution | Worldwide Distribution: Throughout US including Puerto Rico, and the countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, El Salvador, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Mexico, Netherlands, Nicaragua, Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042271 | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES Zimmer, Inc., Oct 13, 2004 |
| K072619 | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS Zimmer, Inc., Nov 21, 2007 |
| K933785 | NEXT GENERATION KNEE SYSTEM Zimmer, Inc., Jan 30, 1995 |
| K960279 | NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES Zimmer, Inc., Apr 26, 1996 |
| K991581 | NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO Zimmer, Inc., Jul 30, 1999 |