POWEREASE Instruments Set Screw Breakoff Instrument recall
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Why was POWEREASE Instruments Set Screw Breakoff Instrument 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # - CA14C107
- Product
- POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 24 units
- Distribution
- US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.
- Recall date
- January 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)