FDA Device recall Z-1011-2018
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty by Zimmer Biomet, citing the affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1011-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-03 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | FL, MD, MI, MO, WI |
Product
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Reason
The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
Identifiers
| code_info | Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900 |
|---|
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-1011-2018%22
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