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U.S. Department of Health and Human Services

Class 2 Device Recall PERSONA (TM)

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 Class 2 Device Recall PERSONA (TM)see related information
Date Initiated by FirmJuly 01, 2014
Date PostedAugust 20, 2014
Recall Status1 Terminated 3 on June 09, 2015
Recall NumberZ-2289-2014
Recall Event ID 68653
Product Classification Tray, surgical, instrument - Product Code FSM
ProductPERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel.
Code Information Item Number 00-5908-015-00, Lot Numbers: 56519125 & 56518861
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-447-5633
Manufacturer Reason
for Recall		The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.
FDA Determined
Cause 2		Device Design
ActionOn July 1, 2014, Zimmer, Inc. issued recall notification to their consignees via e-mail and/or letter. Notification included affected product issue and instructions for returning the affected product. All distributors were notified via electronic mail. Hospital risk managers, as well as distributors with affected inventory were also notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory. Distributors are responsible for returning on-hand affected products to Zimmer and ensuring all of their products are accounted for using the form provided in the letter. Hospital risk managers were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.
Quantity in Commerce190 units
DistributionWorldwide Distribution - USA including AZ, CA, CO, FL, IL, IN, KS, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX & VA and Internationally to AUSTRALIA, FRANCE, INDIA, ITALY, and GERMANY.
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.
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