Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.
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: FDA Class II recall with no reported illnesses or injuries. The defect affects surgical device functionality (fit and removal), representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling 4,235 units of REF 9733235 percutaneous pins (100mm, sterile) due to a potential manufacturing defect.
The pins may have a cross-pin defect that could prevent proper fit into the tap cap or make the pin too tight to remove during surgical procedures.
The affected pins were distributed worldwide, including throughout the United States (Alaska, Alabama, Arizona, California) and multiple countries including Canada, France, Germany, Japan, United Kingdom, and others. The recalled serial numbers are: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, and 2023060369.
Healthcare providers and patients with these pins should contact Medtronic Navigation, Inc. for guidance. Any adverse events or complications should be reported to the FDA.
The recalled product
- Product
- Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 4,235
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: 00613994247872/ Serial Numbers: 2023010549
- 2023010551
- 2023010840
- 2023041134
- 2023051137
- 2023051138
- 2023051139
- 2023060368
- 2023060369
Distribution
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.
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