NDEClass IIImplant

Rod, Fixation, Intramedullary And Accessories, Metallic And Non-collapsible

Orthopedic · 21 CFR 888.3020

MDR events4All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances0All time

Recent MDR events

4 adverse event reports on file

Event type breakdown

Injury4

Most-reported manufacturers

Recalls

1 recall events for this product code

Stryker Howmedica Osteonics Corp.
TerminatedUnknown
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wir
A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
Z-0880-2017 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.