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U.S. Department of Health and Human Services

Class 2 Device Recall Persona Stemmed 5 Degree Cemented Tibia

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  Class 2 Device Recall Persona Stemmed 5 Degree Cemented Tibia see related information
Date Initiated by Firm October 09, 2014
Date Posted November 08, 2014
Recall Status1 Terminated 3 on June 24, 2015
Recall Number Z-0198-2015
Recall Event ID 69397
510(K)Number K113369  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Persona Stemmed 5 Degree Cemented Tibia


Product Usage:
This device is indicated for patients with severe knee pain and disability due to:  Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.  Collagen disorders, and/or avascular necrosis of the femoral condyle.  Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.  Moderate valgus, varus, or flexion deformities.  The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.  This device is intended for cemented use only.
Code Information Part Number 42-5320-079-02 Lot Number 62613813 Part Number 42-5320-071-02 Lot Number 62625781 Part Number 42-5320-075-01 Lot Number 62619031 Part Number 42-5320-075-01 Lot Number 62619040 Part Number 42-5320-079-01 Lot Number 62626696 Part Number 42-5320-071-01 Lot Number 62625790
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 Cleaning process validation failure.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Zimmer sent an Urgent Medical Device Recall letter dated October 9, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer sales representative with the quarantine of any affected product. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759. Hours of operation are Monday through Friday, 8 a.m. through 8 p.m. EST.
Quantity in Commerce 138 units
Distribution US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
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 = JWH and Original Applicant = ZIMMER INC.
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