| Class 2 Device Recall Zimmer Dynesys toploading cutter, spacer | |
Date Initiated by Firm | May 28, 2009 |
Date Posted | November 19, 2009 |
Recall Status1 |
Terminated 3 on October 05, 2011 |
Recall Number | Z-0370-2010 |
Recall Event ID |
51933 |
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 IN 46580-2746
|
For Additional Information Contact | 800-777-7505 |
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 |
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 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.
|
510(K) Database | 510(K)s with Product Code = NQP
|
|
|
|