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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR CD/39 Right

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 Class 2 Device Recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR CD/39 Rightsee related information
Date Initiated by FirmJuly 12, 2018
Create DateOctober 05, 2018
Recall Status1 Terminated 3 on June 27, 2019
Recall NumberZ-0085-2019
Recall Event ID 80845
510(K)NumberK180459 
Product Classification Intraoperative orthopedic joint assessment aid - Product Code ONN
ProductOrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Code Information Lot numbers 20598 and 20607, UDI 00816818021423.
FEI Number 3008592715
Recalling Firm/
Manufacturer		 Orthosensor, Inc.
1855 Griffin Rd Ste A310
Dania FL 33004-2401
For Additional Information ContactMr. 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
ActionLetters 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 Commerce36 devices
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = ONN
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