Recall Z-1980-2012 ยท NKB Thoracolumbosacral Pedicle Screw System
Zimmer, Inc.
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);
| Date | Jul 10, 2012 (initiated Jun 5, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 remo |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100845 | PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES Zimmer Spine, Inc., Sep 21, 2010 |