Stryker Orthopaedics Triathlon Femoral Distal Augment- Left — Class II medical device recall Z-1370-2013
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2013-05-29, distributed nationwide. Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Di
| Recall number | Z-1370-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2013-03-25 |
| Classified | 2013-05-23 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 11 units |
| Reason classes | labeling |
| Model numbers | 5541-A-501 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1370-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.