Z-2227-2017Class II

Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software...

Name: Z-2227-2017 Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software...
Creator: Orthosoft, Inc. dba Zimmer CAS
Published: 2008-06-04
License: https://open.fda.gov/license/

Zimmer CAS / initiated 2008-06-04 / Terminated / root cause: design

FDA source

Orthosoft, Inc. dba Zimmer CAS began a recall of Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems... on 2008-06-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2227-2017
Classification: Class II
Status: Terminated
Initiated: 2008-06-04
Posted: 2017-06-02
Terminated: 2017-06-02
Recalling firm: Zimmer CAS
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
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer CAS conducted a retrospective recall for the Sesamoid Plasty CAS workstation due to the possible risk of injury if the workstation is not properly disassembled. The firm mailed notices dated June 4, 2008. The original Sesamoid Plasty design did not include a safety design feature which is now available on current Sesamoid Plasty Workstations. The Safety design feature is a mechanism that prevents a latch lock at the base of the workstation column from being opened to allow folding of the workstation column for transport after use unless the camera and its arm are first removed from the top of the workstation. A safety label was initially used instead that instructed the user of the recommended disassembly sequence (i.e. camera and arm first). Once consignees receive their replacement system, they were instructed to contact Zimmer CAS Customer Service to assist them with the return (RMA) of the Sesamoid Plasty Workstation. For any questions or concerns please contact the Zimmer CAS customer service, 1-866-336-7846.
Quantity in commerce: 10
Distribution: Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2227-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2227-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02

Product code HAW

K071929Class IINavitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. / cleared 2007-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)