D-RAD Self-Tapping Locking Screw intended for the recall
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING…
Why was D-RAD Self-Tapping Locking Screw intended for the recalled?
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
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 Number 17GM04522
- Product
- D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 59 units
- Distribution
- US, Puerto Rico, Malaysia
- Recall date
- April 18, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)