Medtronic Spinal Surgical Instrument Recall Due to Component Sizing Issue
Medtronic is recalling 24 units of the POWEREASE Set Screw Breakoff Instrument because oversized retaining tabs may prevent proper mating with the set screw.
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 medical device with a functional defect that could compromise surgical performance, but the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 24 units of the POWEREASE Instruments Set Screw Breakoff Instrument, reference number 2346010. This is a spinal surgical instrument manufactured in the United States.
The recall is due to a defect where the retaining tabs component of the Set Screw Retaining Drive may be oversized. This sizing issue may prevent proper mating between the Set Screw Retaining Drive and the set screw.
The affected units were distributed in the United States to the states of California, Kansas, Kentucky, North Carolina, Texas, Washington, Michigan, Ohio, Iowa, Pennsylvania, Oregon, Mississippi, Florida, New York, Georgia, and Arkansas. The specific lot number is CA14C107. Healthcare providers should stop using the affected instruments and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 24
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 # - CA14C107
Distribution
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