NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY — Class II medical device recall Z-1325-2015
Terminated recall by Zimmer Trabecular Metal Technology, Inc., reported 2015-04-01, distributed in CA. One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
| Recall number | Z-1325-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Trabecular Metal Technology, Inc., Parsippany, NJ, United States |
| Recall initiated | 2015-02-04 |
| Classified | 2015-03-26 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2015-07-16 |
| Distributed | CA |
| Quantity | 1 units |
| Reason classes | labeling |
| Lot numbers | 613574282T, 61357484T |
| Model numbers | 00-5490-034-24, 00549003410 |
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 for recall
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1325-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.