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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer PERSONA

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  Class 2 Device Recall Zimmer PERSONA see related information
Date Initiated by Firm November 25, 2014
Date Posted February 03, 2015
Recall Status1 Terminated 3 on December 01, 2015
Recall Number Z-1042-2015
Recall Event ID 70105
510(K)Number K113369  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Code Information Item No. 42-5299-001-00 Affected Lots: 56572679; 56573170; 56574318; 56575056; 56572918; 56573378; 56574538; 56575057; 56572975; 56573379; 56574540; 56575058; 56572978; 56574123; 56574618; 56575059; 56572981; 56574124; 56574619; 56575060; 56572982; 56574223; 56574620; 56575061; 56573071; 56574291; 56574629; 56575062; 56573115; 56574292; 56574630; 56575065; 56573116; 56574316; 56574631; 56575080; 56573154; 56574317; 56575018 
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-613-6131
Manufacturer Reason
for Recall		 Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip
FDA Determined
Cause 2		 Process control
Action On 11/25/2014, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors, hospital Risk Managers and Surgeons with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers, Surgeons, and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-800-348-2759.
Quantity in Commerce 1,091
Distribution Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany.
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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