CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report

Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty recalled

Orthosoft is recalling Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run, distributed in California, Florida. The recall was initiated on 4 Jun 2008 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled10

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2227-2017
FDA event ID: 75609
Recalling firm: Orthosoft, Montreal, N/A
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2008
FDA classified: 2 Jun 2017
Reported: 14 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

4 Jun 2008	Recall initiated by company
2 Jun 2017	Classified by FDA	+3285 days
14 Jun 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

California Florida

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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