| Class 2 Device Recall Persona Personalized Knee System | |
Date Initiated by Firm | September 07, 2012 |
Date Posted | September 28, 2012 |
Recall Status1 |
Terminated 3 on April 17, 2014 |
Recall Number | Z-2493-2012 |
Recall Event ID |
63125 |
510(K)Number | K113369 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Cemented Tibial Drill
Product Usage:
The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone. |
Code Information |
Part 42-5399-018-00, Lots 62034571, 62089766 |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact | Dawn Kindle 574-372-4306 |
Manufacturer Reason for Recall | Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to
three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone.
The investigation into the reports that have been received found that the perforations are occurring while using the
Cemented Tibial Drill. The perforations have o |
FDA Determined Cause 2 | Device Design |
Action | Zimmer sent an Urgent Medical Device Recall dated August 2012 to distributors via electronic mail and Hospital risk managers and surgeons had notifications hand delivered by sales representatives. The recall notice describes the reason for the recall, emphasizes surgical technique to be used, includes instructions for delivering notifications to surgeons and risk managers, instructions for replacing the affected product, and instructions for returning the affected product. Customers were instructed to locate the affected product and contact their sales representative for replacement. Consignees are asked to fill out the Certificate of Delivery, scan it and send back per the instruction provided. |
Quantity in Commerce | 60 |
Distribution | Worldwide Distribution - US Nationwide including the states of: AZ, CA, CO,FL, MN, IL, NJ, NY, OH, OR and the countries of Austrailia, Utd. Arab Emir., France, Germany, India, and Italy. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = JWH
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