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U.S. Department of Health and Human Services

Class 2 Device Recall Persona Partial Knee

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  Class 2 Device Recall Persona Partial Knee see related information
Date Initiated by Firm October 24, 2017
Create Date March 28, 2018
Recall Status1 Terminated 3 on April 03, 2019
Recall Number Z-1240-2018
Recall Event ID 79395
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Persona Partial Knee Spacer Blocks

To assist in partial knee arthroplasty surgery
Code Information 42-5399-035-08/09/10/12/14 (Sizes 8mm, 9mm, 10mm, 12mm, 14mm)  Lot numbers: 63552644 63579568 63547276 63579569 63610265 63549084 63579674 63594433 63610266 63549096 63579676 63594434 63610267 63549097 63579680 63596547 63613101 
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall		 Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.
FDA Determined
Cause 2		 Component design/selection
Action The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/31/2017 to customers titled "Affected Product: Persona Partial Knee Spacer Blocks Size 8mm, 9mm, 10mm, 12mm, 14mm". The letter described the product, problem, and actions to be taken. The letter instructed customers to review the notification and ensure that affected personnel are aware of the contents. Review inventory for affected product which would then be quarantined and ultimately removed by a firm sales representative. The customers were also instructed to complete and return the Certificate of Acknowledgement Form (even if you do not have affected products at your facility) via email to: CorporateQuality.PostMarket@zimmerbiomet.com or Fax to: 574-372-4265. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 430
Distribution US Nationwide 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.
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