Recall Z-1325-2015 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Trabecular Metal Technology, Inc.
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution-Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the N
| Date | Mar 26, 2015 (initiated Feb 4, 2015) |
| Status | Terminated |
| Reason | One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. |
| Root cause | Error in labeling |
| Action | Zimmer Trabecular Metal Technology sent an email dated 12/10/2014 to their sole customer. The customer was requested to return the affected product. |
| Quantity | 1 unit |
| Distribution | US Distribution in the state of CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS Implex Corp., Dec 21, 2004 |