| Class 2 Device Recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR EF/311 Left | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = ONN
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