Recall Z-1483-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 00, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-01-002. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.
| Date | Jun 30, 2009 (initiated Mar 18, 2009) |
| Status | Terminated |
| Reason | The tibial spacer will not affix to the distal surface of the baseplate, as intended. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer, Inc. issued an "Urgent-Device Recall" letter dated March 18, 2009 instructing users to cease using and return the affected product accompanied with a completed Inventory Return Certification form. The inventory Return Certification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. Further questions should be addressed to Zimmer, Inc. at 1-800-613-6131. |
| Quantity | 834 of all products |
| Distribution | Worldwide Distribution - USA including states of CA, NY, MI, OH, WI, IA, MN, NJ, IL, MO, TX, LA, NC, SC, PA, AR, MS, FL, GA, AL, OK, KS, TN, CT, NM, UT, NV, ID and CO and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023528 | NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE Centerplus Orthopedics, Inc., Jan 17, 2003 |