Zimmer CAS Recalls Sesamoid Plasty Workstations Due to Structural Instability
Zimmer CAS is voluntarily recalling 10 Sesamoid Plasty workstations because the top of the unit may fall over during disassembly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of physical injury from a falling object (the workstation top) during disassembly, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Orthosoft, Inc. dba Zimmer CAS is voluntarily conducting a retrospective recall of 10 Sesamoid Plasty, Stereotaxic Instrument workstations. The recall was initiated on June 17, 2008, and covers units distributed worldwide, including in the United States (Florida, California) and in Australia, New Zealand, France, and Brazil.
The recall is due to a risk that the top of the workstation may fall over during disassembly. The affected components are the central structural column and its base, which support the computer and tracking camera. These parts are designed to be folded for transport after use.
The affected units are identified by Part Numbers 521.025/521.028 and Serial Numbers SP-001 through SP-010. Users of these devices should contact the manufacturer for further instructions regarding the recall.
The recalled product
- 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…
- Manufacturer
- Orthosoft, Inc. dba Zimmer CAS
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distribution
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