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[Recalled] 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 co

recall fda device canada

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductSesamoid 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
Brand / manufacturerOrthosoft, Inc. dba Zimmer CAS
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2227-2017
Country of noticeCanada
Risk levelClass II
Hazard typerecall
Notice date04 June 2008

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in Canada and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Orthosoft, Inc. dba Zimmer CAS

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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