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U.S. Department of Health and Human Services

Class 2 Device Recall Continuum Hip Cups

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  Class 2 Device Recall Continuum Hip Cups see related information
Date Initiated by Firm October 01, 2014
Date Posted October 20, 2014
Recall Status1 Terminated 3 on March 02, 2015
Recall Number Z-0094-2015
Recall Event ID 69301
510(K)Number K091508  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
Code Information Part Number: 00-8757-068-02; Lot Number: 62207029
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 products are missing polar boss threads.
FDA Determined
Cause 2		 Equipment maintenance
Action Zimmer sent an "URGENT MEDICAL DEVICE RECALL- LOT SPECIFIC" notifications dated October 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. If you find any product from the affected lot , quarantine the product and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. For patients that previously had this product implanted, it is recommended that you continue your normal post operative follow up routine. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 5:00pm EST.
Quantity in Commerce 19
Distribution Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
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 = JDI and Original Applicant = ZIMMER, INC.
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