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.
Other recalls by Zimmer Trabecular Metal Technology
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FDA Device · Class II · 2019-03-20 · Zimmer Trabecular Metal Technology - NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product…
FDA Device · Class II · 2019-03-20 · Zimmer Trabecular Metal Technology - The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine
FDA Device · Class III · 2017-05-10 · Zimmer Trabecular Metal Technology - 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 A…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology - REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology
All Zimmer Trabecular Metal Technology recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1325-2015%22
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