FDA Device recall Z-1115-2017
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 1…
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 1… by Zimmer Biomet, citing packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1115-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-04 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5
Reason
packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
Identifiers
| code_info | Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Lot Numbers: J3762496 J3762510 J3778480 J3786204 J3…Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Lot Numbers: J3762496 J3762510 J3778480 J3786204 J3803291 J3812133 J3825051 J3833214 J3838037 J3844255 J3848989 J3762497 J3772688 J3779265 J3786205 J3803292 J3812134 J3825052 J3833215 J3844243 J3844256 J3848991 J3762498 J3773147 J3779266 J3786206 J3807380 J3818045 J3826948 J3833216 J3844244 J3844257 J3848992 J3762500 J3773148 J3781773 J3786207 J3807381 J3818046 J3826949 J3834846 J3844246 J3844258 J3848993 J3762501 J3773149 J3781774 J3786209 J3808161 J3818047 J3826950 J3834847 J3844247 J3844259 J3762502 J3775073 J3781775 J3803285 J3808162 J3819257 J3826951 J3834848 J3844248 J3844260 J3762504 J3775074 J3781777 J3803286 J3810188 J3823556 J3826952 J3834849 J3844250 J3847164 J3762506 J3775075 J3781778 J3803287 J3812129 J3823557 J3826954 J3838032 J3844251 J3847165 J3762507 J3775076 J3781779 J3803288 J3812130 J3823558 J3826958 J3838033 J38 |
|---|
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-1115-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.