Recall Z-2227-2017— Orthosoft, Inc. dba Zimmer CAS

Name: FDA recall Z-2227-2017
Creator: U.S. Food and Drug Administration
Published: 2008-06-04

Class II · Terminated

Class II FDA medical device recall by Orthosoft, Inc. dba Zimmer CAS, initiated 2008-06-04, terminated 2017-06-02. It names one FDA 510(k) clearance: K071929. Product: 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: 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..

Recalling firm: Orthosoft, Inc. dba Zimmer CAS
Classification: Class II
Status: Terminated
Initiated: 2008-06-04
Terminated: 2017-06-02
Firm location: Montreal, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K071929 — NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSALOrthosoft, Inc.·cleared 2007-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.