Medtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.
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: The recall involves a risk-of-harm product (sterile medical device) where the hazard is a potential breach of sterility, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the PIN, 9733236, 150MM, STERILE, PERC REF. These are single-use, disposable medical devices distributed nationwide. The recall is limited to Lot No. 2013041109.
The recall was initiated because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. This lack of control raises concerns about the ability to ensure the sterility of the devices.
Healthcare providers and facilities should stop using these specific pins and follow the instructions provided by Medtronic Navigation for the return or disposal of the affected units.
The recalled product
- Product
- PIN, 9733236, 150MM, STERILE, PERC REF
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 26,674
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)
- Lot No.: 2013041109
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 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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