The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0699-2024·Announced 2024-01-17

Medtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues

Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.

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 3/5 (High).

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 of a percutaneous pin with a potential manufacturing defect that could impact proper device fitting and removal. While no injuries have been reported, the defect poses a risk to patients undergoing orthopedic treatment, qualifying it as a risk-of-harm product under the severity rubric.

Plain-English summary

Medtronic Navigation, Inc. is recalling approximately 4,224 REF 9733236 percutaneous pins (150mm, sterile) due to a potential manufacturing defect involving a cross-pin. The defect may render the pins unable to properly fit into the tap cap or cause the pins to be too tight to remove.

The pins were distributed worldwide, including throughout the United States (Alaska, Alabama, Arizona, and California) and internationally to Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Oman, Portugal, Spain, Switzerland, and the United Kingdom.

Affected devices can be identified by Serial Numbers: 2023041143, 2023051122, 2023051457, 2023051458, 2023060918, 2023051459, 2022030438, 2023041136, 2023041141, or by UDI 00613994247865 (or 00643169105669 for devices distributed in Japan).

Patients and healthcare providers should review their inventory of these devices. If you have received any of the affected pins, contact Medtronic Navigation, Inc. for instructions on product return or replacement. Do not use affected devices unless directed to do so by your healthcare provider.

The recalled product

Product
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Orthopedic Surgical Hardware
Hazard
Affected units
4,224

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 (9)

  • UDI: 00613994247865 and 00643169105669(Japan)/ Serial Numbers: 2023041143
  • 2023051122
  • 2023051457
  • 2023051458
  • 2023060918
  • 2023051459
  • 2022030438
  • 2023041136
  • 2023041141

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Navigation, 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 →

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