NexGen¿ Complete Knee Solution Femoral Augment Block Distal only — Class II medical device recall Z-0630-2019
Terminated recall by Zimmer Biomet, Inc., reported 2018-12-26, distributed nationwide. Screw is missing from the package
| Recall number | Z-0630-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-10-31 |
| Classified | 2018-12-18 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2019-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, JP, NL |
| Quantity | 19 units |
| UPC / GTIN / UDI-DI | 00889024224131 |
| Lot numbers | 62925336 |
| Model numbers | 00599003523 |
Product
NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.
Reason for recall
Screw is missing from the package
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-0630-2019. 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.