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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Dynesys toploading cutter, spacer

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 Class 2 Recall
Zimmer Dynesys toploading cutter, spacer
see related information
Date Posted November 19, 2009
Recall Status1 Terminated on October 05, 2011
Recall Number Z-0370-2010
Recall Event ID 51933
Premarket Notification
510(K) Number
K073347 
Product Classification Posterior Metal/Polymer Spinal System, Fusion - Product Code NQP
Product Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
Code Information All lots. Lots 60859166, 60859167, 61085708. 60970745, 61024375, 61024376 and 61123514.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Consignees were notified by letter dated 5/20/09 titled "Urgent Medical Device Correction" that instructed customers that they may continue to use the recalled product until adequate replacements become available, but that they should always ensure they have a backup spacer cutter (of a different model which does not have this issue) available in case this model should jam during use. Users were also advised to ensure the spacer cutter is properly lubricated and is sharp. For questions, please contact Zimmer Spine at 1-800-777-7505.
Quantity in Commerce 177
Distribution Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NQP and Original Applicant = ZIMMER SPINE, INC
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