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U.S. Department of Health and Human Services

Class 2 Device Recall LT CAGE

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  Class 2 Device Recall LT CAGE see related information
Date Initiated by Firm May 27, 2005
Date Posted August 06, 2005
Recall Status1 Terminated 3 on September 20, 2005
Recall Number Z-1090-05
Recall Event ID 32281
PMA Number P970015 
Product Classification Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
Product Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.
Code Information Lot W05C5509.
Recalling Firm/
Manufacturer		 Warsaw Orthopedic, Inc.
2500 Silveus Xing
Warsaw IN 46582-8598
For Additional Information Contact
800-933-2635
Manufacturer Reason
for Recall		 The product is labeled as sterile, but this lot was not sterilized.
FDA Determined
Cause 2		 Other
Quantity in Commerce 140
Distribution United States and Canada.
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.
PMA Database PMAs with Product Code = MAX and Original Applicant = SOFAMOR DANEK
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