Recall Z-0370-2010 ยท NQP Posterior Metal/Polymer Spinal System, Fusion
Zimmer Inc.
Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
| Date | Nov 19, 2009 (initiated May 28, 2009) |
| Status | Terminated |
| Reason | The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay. |
| Root cause | Other |
| 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 | 177 |
| Distribution | Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc., Feb 8, 2008 |