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U.S. Department of Health and Human Services

Class 2 Device Recall Persona" Trabecular Metal" Tibia Plate Instruments and Modular Brackets

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  Class 2 Device Recall Persona" Trabecular Metal" Tibia Plate Instruments and Modular Brackets see related information
Date Initiated by Firm May 11, 2016
Date Posting Updated June 07, 2016
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-1917-2016
Recall Event ID 74148
510(K)Number K121771  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
Product Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
Code Information 2;, 42539806401, 62214944, 10/22/2012;, 42539806702, 62214945, 10/18/2012;.
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall
Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.
FDA Determined
Cause 2
Component design/selection
Action Zimmer Inc. is initiating a voluntary recall of Persona" Trabecular Metal" Tibia / Tibial Plate Instruments and Modular Brackets following an increase in complaints of radiolucent lines and loosening, and earlier recall of the Persona" Trabecular Metal" Tibial Plates . All sizes and lots of the affected devices are being removed from distribution. Recall notices were issued to affected distributors, hospitals, and surgeons on 05/11/2015 via mail. Customers may contact the following with any questions: 1-877-946- 2761 between 8:00 am and 5:00pm EST. Customers are asked to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist Zimmer Biomet sales representative with the quarantine of any affected product. 3. Zimmer Biomet sales representative will remove the recalled product from customer facilities. 4. Complete the Certificate of Acknowledgement Form and return to: corporatequality.postmarket@zimmerbiomet.com.
Quantity in Commerce 10,256
Distribution Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI; Foreign: Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, France, Luxembourg, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Arab Emirates.
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.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = ZIMMER, INC.
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