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U.S. Department of Health and Human Services

Class 2 Device Recall PERSONA THE PERSONALIZED KNEE SYSTEM

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 Class 2 Device Recall PERSONA THE PERSONALIZED KNEE SYSTEMsee related information
Date Initiated by FirmDecember 12, 2017
Create DateMarch 27, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall NumberZ-1224-2018
Recall Event ID 79394
510(K)NumberK122765 
Product Classification U.V. Method, cpk isoenzymes - Product Code JHW
ProductPERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Code Information Item# 42-5320-067-02 Lot # 63236047
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
574-267-6131
Manufacturer Reason
for Recall		A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn December 12, 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers will the following guidance: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. Questions or concerns can be directed to 1-574-371-3071.
Quantity in Commerce3 units
DistributionNon-USA Customer
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 = JHW
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