Medtronic Recalls Two Angled Drills Due to Tip Extension Discrepancy
Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.
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, and the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a manufacturing discrepancy (tip extension length) rather than a high-risk pathogen or structural failure with reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling two units of the Medtronic ANGLED DRILL, REF 6630902. The recall was initiated after the company discovered that the product lot in question had a drill tip extension that was longer than what is indicated on the print specification.
The affected units are identified by UDI 00643169363502 and Lot Number EM17F015. These units were distributed to Minnesota and North Carolina. The source text does not specify the number of patients affected or report any injuries or illnesses associated with the use of these devices.
Healthcare providers and consumers should stop using the affected devices and contact Medtronic for further instructions or a replacement. The source text does not provide specific contact information or a deadline for the recall.
The recalled product
- Product
- Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 2
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 (2)
- UDI: 00643169363502
- Lot Number EM17F015
Distribution
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