Recall StatusTerminated
Date Initiated2016-05-11
Date Terminated2017-06-02
Product Quantity10,256
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.
Firm 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:
[email protected].
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.