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U.S. Department of Health and Human Services

Class 2 Device Recall Sesamoid Plasty

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  Class 2 Device Recall Sesamoid Plasty see related information
Date Initiated by Firm June 04, 2008
Create Date June 02, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-2227-2017
Recall Event ID 75609
510(K)Number K071929  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
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
Code Information 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
Recalling Firm/
Manufacturer		 Orthosoft, Inc. dba Zimmer CAS
75 Queen St #3300
Montreal Canada
For Additional Information Contact Kevin Escapule
574-372-4487
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = ORTHOSOFT, INC.
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