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 be folded onto itself for ease of transport after use. This is a retrospective recall report for a re Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 the top of the workstation. A safety label was initially used instead that instructed the user of the recommended disassembly sequence (i.e. camera and arm first). Once consignees receive their replacement system, they were instructed to contact Zimmer CAS Customer Service to assist them with the return (RMA) of the Sesamoid Plasty Workstation. For any questions or concerns please contact the Zimmer CAS customer service, 1-866-336-7846.

Distribution

As reported by FDA

CA, FL