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U.S. Department of Health and Human Services

Class 2 Device Recall Persona Cemented Tibial Broach Inserter/Extractor

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  Class 2 Device Recall Persona Cemented Tibial Broach Inserter/Extractor see related information
Date Initiated by Firm December 04, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on May 13, 2015
Recall Number Z-0853-2015
Recall Event ID 69906
510(K)Number K113369  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Persona Cemented Tibial Broach Inserter/Extractor.

The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
Code Information Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754 
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected and the magnet cover was not identified. The investigation indi
FDA Determined
Cause 2		 Process design
Action Notifications will be sent to the affected distributors and hospital risk managers with instructions for returning the affected product the week of December 8, 2014. Recalled product will be quarantined and returned to Zimmer Sales Representatives to be destroyed. The public contact for the recall is: Consumer Relations Call Center Zimmer, Inc. P O Box 708 Warsaw, IN 46581-0708 consumer@zimmer.com Phone: 1-800-447-5633 Fax: 574-371-8755
Quantity in Commerce 83 units
Distribution Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy.
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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