FDA Device recall Z-1325-2015
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only by Zimmer Trabecular Metal Technology, citing one unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1325-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-04 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer Trabecular Metal Technology |
| Distribution | CA |
Product
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 NexGen Complete Knee Solution-Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
Reason
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Identifiers
| code_info | 20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1325-2015%22
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