Date Initiated by Firm | June 05, 2012 |
Date Posted | July 10, 2012 |
Recall Status1 |
Terminated 3 on September 03, 2014 |
Recall Number | Z-1980-2012 |
Recall Event ID |
62325 |
510(K)Number | K100845 |
Product Classification |
Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
|
Product | Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile.
Product Usage:
The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimally invasive surgery to fuse the spine. Per the surgical technique (Ll554 Pathfinder NXT Surgical Technique); |
Code Information |
Part numbers 3573-1 (angle handle) all lots including 64PY, 67YA, 69FF, 71GB, 72JL, 73GY |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | David J. Kunz 574-372-4807 |
Manufacturer Reason for Recall | Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery. |
FDA Determined Cause 2 | Device Design |
Action | Zimmer sent an Urgent Medical Device Correction and Removal notification dated June 5, 2012 to distributors and all affected accounts of Zimmer Spine. The notice identified the affected products, problem and actions to be taken. Distributors were asked to hand deliver Recall Notices to Surgeons and return the completed Surgeon Contact Certification Form within 10 working days to ronald.musselman@zimmer.com or FAX to 1-512-258-0995. Notices to Surgeons and User facilities included revised directions/precautions for the Instructions for Use and attached Surgical Techique. Devices will be removed once newly design parts become available.
For any related questions or assistance about this please contact Zimmer Spine Customer Service at 866-774-6368. |
Quantity in Commerce | 249 ( angle handle and straight) in total |
Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the 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 = NKB
|