Recall Z-2439-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Inc.
TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
| Date | Sep 20, 2010 (initiated Jul 5, 2010) |
| Status | Terminated |
| Reason | Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. |
| Root cause | Labeling mix-ups |
| Action | Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and U |
| Quantity | 50 total |
| Distribution | Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040630 | TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ Implex Corp., Sep 30, 2004 |