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TRIAX
Stryker GmbH · Model 5150-2-471 · UDI-DI 07613327079012
JEC
Prescription
1
510(k) clearances
298
Adverse events (1 deaths)
6
Recalls
61
Facilities
Description
Carbon Tube; Red
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-06-18 | Anjon Holdings | High rate of galling of one threaded component. |
| 2019-11-21 | Stryker GmbH | Pin To Rod Coupling could not clamp the pin and rod as intended |
| 2018-06-21 | Ossur Americas | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium |
| 2016-09-14 | Hand Biomechanics Lab Inc | A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty |
| 2008-07-09 | Acumed LLC | Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw. |
| 2005-08-17 | Stryker Howmedica Osteonics Corp. | Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.