Medtronic Recalls Sterile Drill Bits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 sterile drill bits because returned devices may not have been properly examined for damage that could compromise sterility.
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 2/5 (Moderate).
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. The hazard is a potential loss of sterility due to inadequate inspection of returned devices, which is a significant quality control issue but does not meet the criteria for Severe (Class II with hospitalization reports) or High (high-risk pathogens without reported illness). It fits the Moderate category for a voluntary precautionary recall regarding process control.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of BIT 9733516 2.9mm DRILL STERILE. These are single-use, disposable medical devices distributed nationwide. The recall is limited to Lot No. 130204G.
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 examination could fail to ensure the sterility of the devices.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- BIT 9733516 2.9mm DRILL STERILE
- 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.: 130204G
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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