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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 22, 2005
Date PostedSeptember 21, 2005
Recall Status1 Terminated 3 on July 07, 2012
Recall NumberZ-1547-05
Recall Event ID 31392
510(K)NumberK033804 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
ProductProduct is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver***STERILE***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.
Code Information Lot # ''s BBB34096, BBB35001, BBB38590, BBB47862, BBB56209, BBB59492, BBB61957, BBB63207, BBB66991, BBB69760, BBB70775.
Recalling Firm/
Manufacturer		 Linvatec Corp.
11311 Concept Blvd
Largo FL 33773-4908
Manufacturer Reason
for Recall		Linvatec has determined that there is a possibility that the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.
FDA Determined
Cause 2		Other
ActionLinvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
Quantity in Commerce1,055 Units
DistributionProduct was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
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 = JDI
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