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 removal initiated on 17 June 2008
This recall has been terminated (originally issued June 4, 2008).
- Company
- Orthosoft, Inc. Dba Zimmer Cas
- Recall Initiated
- June 4, 2008
- Terminated
- June 2, 2017
- Recall Number
- Z-2227-2017
- Quantity
- 10
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
Lot / Code Info
Part Number and : 521.025/521.028; Lot Number/Serial Numbers: SP-001, SP-002, SP-003, SP-004, SP-005, SP-006, SP-007, SP-008, SP-009, SP-010
Root Cause
Device Design
Action Taken
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.