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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. It is a precautionary recall regarding process controls for sterility assurance, fitting the 'voluntary precautionary recalls' criterion for a Moderate score.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of PIN, 9733235, 100MM, STERILE, PERC REF. These are single-use, disposable medical devices distributed nationwide. The affected lots are 2012110744, 2013010347, and 2012081458.
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 contact Medtronic Navigation for further instructions on handling and returning the affected units.
The recalled product
- Product
- PIN, 9733235, 100MM, 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.: 2012110744 2013010347 2012081458
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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