FDA Device recall Z-1370-2013
Stryker Orthopaedics Triathlon Femoral Distal Augment- Left
- FDA Device
- Class II
- terminated
- Published 2013-05-29
On 2013-05-29 the FDA classified a Class II recall of Stryker Orthopaedics Triathlon Femoral Distal Augment- Left by Stryker Howmedica Osteonics, citing stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1370-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-25 |
| Published | 2013-05-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 Meyzieu, Cedex, France This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone
Reason
Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
Identifiers
| code_info | Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1370-2013%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.