Date Initiated by Firm |
July 12, 2018 |
Create Date |
October 05, 2018 |
Recall Status1 |
Terminated 3 on June 27, 2019 |
Recall Number |
Z-0086-2019 |
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 G-H/7-12 Left, REF ZBH-PSNCRGH712-L. |
Code Information |
Lot numbers 20549, 20565, 20606, 20610, 20615, UDI 00816818021454. |
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 |
84 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.
|
510(K) Database |
510(K)s with Product Code = ONN and Original Applicant = OrthoSensor, Inc.
|