Sesamoid Plasty — Class II medical device recall Z-2227-2017
Terminated recall by Orthosoft, Inc. dba Zimmer CAS, reported 2017-06-14, distributed in CA, FL. Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of t
| Recall number | Z-2227-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthosoft, Inc. dba Zimmer CAS, Montreal, N/A, Canada |
| Recall initiated | 2008-06-04 |
| Classified | 2017-06-02 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2017-06-02 |
| Distributed | CA, FL |
| Countries outside the US | BR, FR, NZ |
| Quantity | 10 |
| Serial numbers | SP-001, SP-002, SP-003, SP-004, SP-005, SP-006, SP-007, SP-008, SP-009, SP-010 |
| Model numbers | 521.025/521.028 |
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 removal initiated on 17 June 2008
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2227-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.