CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report

Pathfinder NXT Fixed Percutaneous Rod Holder recalled by Zimmer

Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle), distributed nationwide in the US. The recall was initiated on 5 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart numbers 3573-1 (angle handle) all lots including 64PY, 67YA, 69FF, 71GB, 72JL, 73GY

Quantity recalled249 ( angle handle and straight) in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1980-2012
FDA event ID: 62325
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 5 Jun 2012
FDA classified: 10 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Spinal Implants

Timeline

5 Jun 2012	Recall initiated by company
10 Jul 2012	Classified by FDA	+35 days
18 Jul 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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);

Where it was distributed

Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.

Nationwide

Questions about this recall

Is Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) recalled?

Yes. Zimmer recalled Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) on 5 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-1980-2012.

Why was it recalled?

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.

Which lots are affected?

Part numbers 3573-1 (angle handle) all lots including 64PY, 67YA, 69FF, 71GB, 72JL, 73GY

Where was it sold?

Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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