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U.S. Department of Health and Human Services

Class 2 Device Recall Microvent

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  Class 2 Device Recall Microvent see related information
Date Initiated by Firm January 13, 2004
Date Posted July 23, 2004
Recall Status1 Terminated 3 on September 01, 2004
Recall Number Z-1141-04
Recall Event ID 28217
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product Microvent Implant Line
Code Information MicroVent Implant Line   Part # Description Lot Number Quantity MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0200515 100 MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0202923 100 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 014962 270 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 0200428 200 MV3H8 Impl, M-V II, HA, 3.7mm, 8mm 0202162 30 MV4H10 Impl, M-V II, HA, 4.7mm, 10mm 0200516 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 016646 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 0200427 100 MV4H8 Impl, M-V II, HA, 4.7mm, 8mm 0201180 35 
Recalling Firm/
Manufacturer		 Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
Manufacturer Reason
for Recall		 Sterility barrier compromised.
FDA Determined
Cause 2		 Other
Quantity in Commerce See Codes
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.
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