FDA Device recall Z-0610-2013
Stryker Howmedica Osteonics
- FDA Device
- Class II
- terminated
- Published 2013-01-02
On 2013-01-02 the FDA classified a Class II recall of Stryker Howmedica Osteonics by Stryker Howmedica Osteonics, citing during the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0610-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-06 |
| Published | 2013-01-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Howmedica Osteonics |
| Distribution | US |
Product
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive,
Reason
During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube.
Identifiers
| code_info | Catalog No: 1806-0073S Lot Code:123596 |
|---|
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-0610-2013%22
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