NexGen Augment — Class II medical device recall Z-1575-2015
Terminated recall by Zimmer, Inc., reported 2015-05-13, distributed in FL, IL, IN, MN. The affected lot is being recalled because it was packaged without the locking screw. The locking screw packag
| Recall number | Z-1575-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-04-02 |
| Classified | 2015-05-01 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-09-23 |
| Distributed | FL, IL, IN, MN |
| Countries outside the US | AR, DE |
| Quantity | 20 units |
| Lot numbers | 62815809 |
| Model numbers | 00-5990-036-10 |
Product
NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
Reason for recall
The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery
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-1575-2015. 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.