Medtronic Set Screw Retaining Driver Recalled Due to Component Sizing Issue
Medtronic is recalling seven Set Screw Retaining Drivers because oversized retaining tabs may prevent proper mating with set screws.
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 is classified as FDA Class II, and the defect involves a functional failure in a surgical instrument where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling seven units of the Set Screw Retaining Driver (Ref 9010000820). This is an orthopedic manual surgical instrument used in medical procedures.
The recall was initiated because the retaining tabs component of the device may be oversized. This defect prevents proper mating between the Set Screw Retaining Driver and the set screw, potentially compromising the instrument's function during use.
The affected units were distributed in the United States to the states of California, North Carolina, Texas, Indiana, New Jersey, and Michigan. The specific lot code for the recalled items is TI13J01811. Healthcare facilities and users should stop using these instruments and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 7
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)
- TI13J01811
Distribution
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