Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
FDA Recall Z-0370-2010 · Posted 2009-11-19
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeNQP
Date Initiated2009-05-28
Date Terminated2011-10-05
Product Quantity177
Reason for Recall
The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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