FDA Device recall Z-1512-2018
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplast…
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplast… by Howmedica Osteonics, citing firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1512-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-12 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Howmedica Osteonics |
| Distribution | n/a |
Product
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Reason
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Identifiers
| code_info | Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A |
|---|
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-1512-2018%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.