Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the track...

FDA Device Recall #Z-2227-2017 - Class II, June 4, 2008

Recall Summary

Recall Number Z-2227-2017
Classification Class II - Moderate risk
Date Initiated June 4, 2008
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Orthosoft, Inc. dba Zimmer CAS
Location Montreal, N/A
Product Type Devices
Quantity 10

Product Description

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

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 Pattern

Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil

Lot / Code Information

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

Other Recalls from Orthosoft, Inc. dba Zimmer CAS

Recall # Classification Product Date
Z-0721-2022 Class II NavitrackER Kit A: Knee, Model Number 20-8000-0... Jan 7, 2022
Z-1868-2017 Class II SmartTools Knee System Orthopedic Stereotaxic ... Feb 20, 2017
Z-1881-2017 Class II Navitrack System - OS Knee Universal, Orthopedi... Oct 6, 2011
Z-2048-2017 Class II NDI P7 Position Sensor, Stereotaxic Instrument Jun 9, 2009
Z-2076-2017 Class II Navitrack System - OS Knee Universal, Stereotax... Oct 28, 2008

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.