Medtronic Recalls Single-Use Ref Frame Driver Kits Due to Sterility Concerns
Medtronic Navigation is recalling 26,674 single-use Ref Frame Driver Kits because returned devices may not have been properly examined for damage to ensure 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 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: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the INST 9731132 KIT CR REF FRAME DRIVER 5PK. These are single-use, disposable medical devices distributed nationwide. The recall is limited to Lot No. r683.
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.
Consumers and healthcare providers should stop using the affected devices and contact Medtronic Navigation for further instructions on how to return or dispose of the product.
The recalled product
- Product
- INST 9731132 KIT CR REF FRAME DRIVER 5PK
- 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.: r683
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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