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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR EF/311 Left

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  Class 2 Device Recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR EF/311 Left see related information
Date Initiated by Firm July 12, 2018
Create Date October 05, 2018
Recall Status1 Terminated 3 on June 27, 2019
Recall Number Z-0082-2019
Recall Event ID 80845
510(K)Number K180459  
Product Classification Intraoperative orthopedic joint assessment aid - Product Code ONN
Product OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Code Information Lot numbers 20568, 20575, 20581, 20584, 20621, 20623, and 20628, UDI 00816818021430.
Recalling Firm/
Manufacturer		 Orthosensor, Inc.
1855 Griffin Rd Ste A310
Dania FL 33004-2401
For Additional Information Contact Mr. Jack Leo
954-577-7770
Manufacturer Reason
for Recall		 Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
FDA Determined
Cause 2		 Under Investigation by firm
Action Letters dated 7/12/2018 were either delivered by the sales representatives or issued via email to their consignees on 7/13/2018 explaining the reason for recall and requesting return of the devices, if still available, for replacement. The firm expanded the recall via letter dated 8/29/2018 for delivery by sales representatives or via sales representative email on 8/30/2018.
Quantity in Commerce 41 devices
Distribution Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
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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