FDA Device recall Z-0628-2018
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804 by Zimmer Biomet, citing the affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0628-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-25 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
Reason
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Identifiers
| code_info | Model No. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080), 305410 ((01)00880304240247(17)220601(10)305410). |
|---|
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-0628-2018%22
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