Recall Z-1980-2012— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2012-06-05, terminated 2014-09-03. It names one FDA 510(k) clearance: K100845. 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);. 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..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-05
- Terminated
- 2014-09-03
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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);
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.