Device 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);
Z-1980-2012
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 62325
- Status
- Terminated
- Classification
- Class II
- Quantity
- 249 ( angle handle and straight) in total
- Official record key
device-enforcement:Z-1980-2012
Official wording
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.
Code information: Part numbers 3573-1 (angle handle) all lots including 64PY, 67YA, 69FF, 71GB, 72JL, 73GY
Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
Derived failure modes
-
Unknown
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.