FDA Device recall Z-3249-2018
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty by Zimmer Biomet, citing the implant only has one bolt in the sterile package but it should have had two.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3249-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-02 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Reason
The implant only has one bolt in the sterile package but it should have had two.
Identifiers
| code_info | Lot 320390, UDI (01) 0088030448157 (17) 230129 (10) 320390 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3249-2018%22
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