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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 Metalsee related information
Date Initiated by FirmNovember 16, 2011
Create DateJune 26, 2015
Recall Status1 Terminated 3 on August 28, 2013
Recall NumberZ-0368-2012
Recall Event ID 60419
510(K)NumberK994286 
Product Classification Hip Prosthesis - Product Code LPH
ProductZimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER STANDARD 40 MM NECK OFFSET CONE BODY SIZE C 35 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9996-019-35
Code Information Item number: 00-9996-019-35 Lot number: 00104621
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information ContactCheryl 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
ActionOn 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 Commerce1 unit (Distributed to Demark)
DistributionWorldwide distribution: USA (NY), AUSTRALIA, SWITZERLAND, and DENMARK
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LPH
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