Agency classClass IIOur severity:Severe FDA (Devices)·Z-1980-2012·Announced 2012-07-18

Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking

Zimmer, Inc. is recalling Pathfinder NXT Fixed Percutaneous Rod Holders because the tip may crack or break during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device used during surgery, which poses a risk of significant injury.

Plain-English summary

Zimmer, Inc. is recalling the Pathfinder NXT Fixed Percutaneous Rod Holder, part number 3573-1 (angle handle). The device is made of stainless steel and silicone rubber and is used to hold a rod for insertion into screw heads during minimally invasive spine surgery.

The recall was initiated because complaints were received indicating that the rod holder tip may crack or break when the rod is manipulated during surgery. A total of 249 units, including angle handle and straight configurations, are affected. The specific lots involved include 64PY, 67YA, 69FF, 71GB, 72JL, and 73GY.

The affected products were distributed worldwide, including nationwide in the United States and in Austria, Australia, Belgium, France, Germany, Italy, Spain, Switzerland, and the United Kingdom. Healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions.

The recalled product

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…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Surgical Instrument
Hazard: structural-failure
surgical-injury
Affected units: 249

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Zimmer, Inc.

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