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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM

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  Class 2 Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM see related information
Date Initiated by Firm December 05, 2014
Date Posted January 29, 2015
Recall Status1 Terminated 3 on March 13, 2015
Recall Number Z-1029-2015
Recall Event ID 69963
510(K)Number K130380  
Product Classification Intraoperative orthopedic joint assessment aid - Product Code ONN
Product Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Code Information Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.
Recalling Firm/
Manufacturer		 Orthosensor, Inc.
1560 Sawgrass Corporate Pkwy
4th Floor
Sunrise FL 33323-2858
For Additional Information Contact Brandy Krier
954-577-7770
Manufacturer Reason
for Recall		 Presence of one inoperable (dead) sensor pad.
FDA Determined
Cause 2		 Under Investigation by firm
Action OrthoSensor sent an Recall letter dated December 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users " Remove the above-referenced serial numbers from your VERASENSE inventory and quarantine. " Complete the enclosed Customer Response Form. Actions to be taken by OrthoSensor " You will be credited for these devices for your full purchase amount. The Returned Materials Authorization (RMA) number for each device in your possession is listed above. " OrthoSensor will replenish these devices as soon as they are available. For further questions please call (954) 577-7770.
Quantity in Commerce 22 devices
Distribution US Distribution to the states of : IL, MI, NY, CA, VA and NV.
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 = ONN and Original Applicant = ORTHOSENSOR, INC.
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