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Class 2 Device Recall |
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Date Initiated by Firm |
February 22, 2005 |
Date Posted |
September 21, 2005 |
Recall Status1 |
Terminated 3 on July 07, 2012 |
Recall Number |
Z-1551-05 |
Recall Event ID |
31392 |
510(K)Number |
K013131
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Product |
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''. |
Code Information |
Lot #''s BBB32078, BBB34094, BBB34999, BBB35880, BBB38626, BBB48838, BBB49880, BBB59210, BBB53860, BBB55923, BBB59491, BBB65474, BBB66408, BBB68488, BBB31428, BBB34095, BBB35002, BBB36673, BBB48839, BBB51999, BBB55022, BBB59493, BBB66410, BBB35055, BBB50780, BBB61023, BBB34089, BBB35879, BBB37714, BBB48840, BBB52911, BBB55921, BBB65475, BBB30602, BBB31323, BBB49881, BBB52912, BBB67472, BBB52000. |
Recalling Firm/ Manufacturer |
Linvatec Corp. 11311 Concept Blvd Largo FL 33773-4908
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Manufacturer Reason for Recall |
Linvatec has determined there is a possibility 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.
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FDA Determined Cause 2 |
Other |
Action |
Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method. |
Quantity in Commerce |
3,273 Units |
Distribution |
Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates). |
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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.
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510(K) Database |
510(K)s with Product Code = and Original Applicant = LINVATEC CORP.
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