The Recall Desk
HighFDA (Devices)·Z-1022-2025·Announced 2025-02-05

Medtronic Percutaneous Reference Pins May Not Fit Properly

Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall affecting a surgical device used in image-guided procedures. A fit failure could compromise proper positioning during surgery. No illnesses or injuries have been reported, so per the rubric, the score does not exceed 3 for risk-of-harm products without reported injury.

Plain-English summary

Medtronic Navigation, Inc. is recalling Sterile Percutaneous Reference Pins in 100mm and 150mm sizes distributed worldwide. The pins are used to attach a patient reference frame during computer-assisted image-guided surgeries to maintain proper positioning and tracking throughout the procedure.

The pins may not fit into the patient reference frame or percutaneous pin adapter, according to an increase in complaints received by the manufacturer. This fit failure could prevent proper attachment of the reference system during surgery.

Approximately 67,370 pins have been distributed to the United States nationwide and to numerous countries including Canada, Australia, Japan, South Korea, United Kingdom, and others. Hospitals and surgical centers should verify whether they have affected units by checking the provided serial and lot numbers and contact Medtronic Navigation, Inc. for instructions on the recall.

The recalled product

Product
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a pat
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Surgical Navigation / Reference Frame
Hazard
Affected units
67,370

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 (1)

  • Sterile Percutaneous Pin

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Related recalls

Same manufacturer · Medtronic Navigation, Inc.

See all →