Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
POWEREASE Instruments Set Screw Breakoff Instrument Recalled by Medtronic Sofamor Danek USA Inc Due to The retaining tabs component of the Set Screw...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Sofamor Danek USA Inc directly.
Affected Products
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Quantity: 24 units
Why Was This Recalled?
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
Where Was This Sold?
This product was distributed to 16 states: AR, CA, FL, GA, IA, KS, KY, MI, MS, NY, NC, OH, OR, PA, TX, WA
About Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek USA Inc has 81 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report