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Recall Observatory FDA recall evidence

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

June 05, 2012

Class II

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

    reason.no_named_rule · v1.0.0

    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.