Orthosoft, Inc. dba Zimmer CAS 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 r Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 r
Brand
Orthosoft, Inc. dba Zimmer CAS
Lot Codes / Batch Numbers
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
Products Sold
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
Orthosoft, Inc. dba Zimmer CAS is recalling Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking due to 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. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL
Page updated: Jan 11, 2026