Reported Jun 14, 2017 · Terminated
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of…
Orthosoft, Inc. dba Zimmer CAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthosoft, Inc. dba Zimmer CAS · 75 Queen St #3300 · Montreal, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
- Part Number and521.025/521.028
- Lot Number/Serial Numbers
SP-001SP-002SP-003SP-004SP-005SP-006SP-007SP-008SP-009SP-010
- Amount recalled
- 10
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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