SET Screw Retaining Driver recall
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
Why was SET Screw Retaining Driver 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?
TI13J01811
- Product
- SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 7 units
- Distribution
- US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
- Recall date
- February 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)