FDA Device recall Z-1462-2018
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us…
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us… by Howmedica Osteonics, citing customers may receive the incorrect size implant from what is labeled on the box.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1462-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-30 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Reason
Customers may receive the incorrect size implant from what is labeled on the box.
Identifiers
| code_info | Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A |
|---|
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-1462-2018%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.