Medical Device Recalls

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New Search Back to Search Results   Class 2 Recall Zimmer Dynesys top-loading cutter, spacer Date Posted November 19, 2009 Recall Number Z-0370-2010 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 Reason for Recall The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay. 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.