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U.S. Department of Health and Human Services

Class 2 Device Recall ZMR Trabecular Metal

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  Class 2 Device Recall ZMR Trabecular Metal see related information
Date Initiated by Firm November 16, 2011
Create Date June 26, 2015
Recall Status1 Terminated 3 on August 28, 2013
Recall Number Z-0367-2012
Recall Event ID 60419
510(K)Number K994286  
Product Classification Hip Prosthesis - Product Code LPH
Product Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems:

FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER EXTENDED 46 MM NECK OFFSET SPOUT BODY SIZE E 55 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9991-021-55
Code Information Item number: 00-9991-021-55 Lot number: 00104623
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Cheryl A. Trease
574-372-4807
Manufacturer Reason
for Recall		 Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined. " Stop using the affected lots and place affected product in quarantine. " Review available product on the shelf " Identify those part/lot combinations listed in the recall communication " Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine " Return affected lots and signature of acknowledgement to Zimmer
Quantity in Commerce 1 unit (International Only Switzerland)
Distribution Worldwide distribution: USA (NY), AUSTRALIA, SWITZERLAND, and DENMARK
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 = LPH and Original Applicant = ZIMMER, INC.
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