Home › Arbutus Medical Inc › Arbutus Medical
Arbutus Medical
Arbutus Medical Inc · Model SteriTrak · UDI-DI 00844107000583
JEC
Prescription
10
510(k) clearances
298
Adverse events (1 deaths)
6
Recalls
61
Facilities
Description
SteriTrak is a sterile, temporarily implantable Kirschner wire (K-wire) intended to be implanted into any bone for the purposes of providing an anchor for skeletal traction.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.