NexGenTrabecular Metal Tibial Half Block Augment — Class II medical device recall Z-1005-2019
Terminated recall by Zimmer Trabecular Metal Technology, Inc., reported 2019-03-20, distributed nationwide. Potentially comingled, resulting in the product in the box potentially not matching the product on the label
| Recall number | Z-1005-2019 |
|---|---|
| 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 | 2019-02-01 |
| Classified | 2019-03-11 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2020-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, JP, NL |
| Quantity | 24 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889024307858 |
| Lot numbers | 63253751, 63257915, 63291542 |
| Model numbers | 00544800426 |
Product
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are 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 Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.
Reason for recall
Potentially comingled, resulting in the product in the box potentially not matching the product on the label
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-1005-2019. 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.