Recall Z-2227-2017 ยท HAW Neurological Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can
| Date | Jun 4, 2008 |
| Status | Terminated |
| Reason | Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly. |
| Root cause | Device Design |
| Action | Zimmer CAS conducted a retrospective recall for the Sesamoid Plasty CAS workstation due to the possible risk of injury if the workstation is not properly disassembled. The firm mailed notices dated June 4, 2008. The original Sesamoid Plasty design did not include a safety design feature which is now available on current Sesamoid Plasty Workstations. The Safety design feature is a mechanism that prevents a latch lock at the base of the workstation column from being opened to allow folding of the workstation column for transport after use unless the camera and its arm are first removed from |
| Quantity | 10 |
| Distribution | Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071929 | NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL Orthosoft, Inc., Sep 19, 2007 |