Home › Device types › JEC
Component, Traction, Invasive
FDA product code JEC · Class 2 · Orthopedic
610
Registered devices
298
Adverse events
6
Recalls
85
510(k) clearances
Devices with this code
Anjon Bremer Halo System — ANJON HOLDINGS LLCFragment Fixation System — ORTHOFIX SRLAnjon Bremer Halo System — ANJON HOLDINGS LLCMEDLINE — MEDLINE INDUSTRIES, INC.HOFFMANN — Stryker GmbHFragment Fixation System — ORTHOFIX SRLSHEFFIELD RING FIXATOR — ORTHOFIX SRLFragment Fixation System — ORTHOFIX SRLSHEFFIELD RING FIXATOR — ORTHOFIX SRLHOFFMANN — Stryker GmbHFragment Fixation System — ORTHOFIX SRLMEDLINE — MEDLINE INDUSTRIES, INC.MEDLINE — MEDLINE INDUSTRIES, INC.Anjon Bremer Halo System — ANJON HOLDINGS LLCHOFFMANN — Stryker GmbHMEDLINE — MEDLINE INDUSTRIES, INC.Anjon Bremer Halo System — ANJON HOLDINGS LLCMEDLINE — MEDLINE INDUSTRIES, INC.MEDLINE — MEDLINE INDUSTRIES, INC.SHEFFIELD RING FIXATOR — ORTHOFIX SRLSHEFFIELD RING FIXATOR — ORTHOFIX SRLFragment Fixation System — ORTHOFIX SRLSHEFFIELD RING FIXATOR — ORTHOFIX SRLAnjon Bremer Halo System — ANJON HOLDINGS LLC
Recent 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 descript |
| 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 exp |
| 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 missin |
| 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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