Z-2227-2017 Class II Terminated

Recalled by Orthosoft, Inc. dba Zimmer CAS — Montreal, N/A

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
June 4, 2008
Termination Date
June 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product 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

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