Recall Z-2091-2012 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Inc.
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
| Date | Jul 27, 2012 (initiated Apr 30, 2012) |
| Status | Terminated |
| Reason | The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall |
| Root cause | Component design/selection |
| Action | Zimmer sent an Urgent Medical Device Recall letter dated April 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Requests for alternative instruments should be requested by calling (574) 372-4470. Fax Back Inventory Return Certification Form is to be sent back to Zimmer at (574) 372-4265. All recalled instruments available at the distributor are to be returned to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. The Distributor notice included instructions to notify surgeons immedia |
| Quantity | 1662 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031061 | NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Zimmer, Inc., Oct 9, 2003 |