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 SCREW, REF 74692410, QTY (1), STERILE R
This recall has been terminated (originally issued March 20, 2018).
- Company
- Smith & Nephew Inc
- Recall Initiated
- March 7, 2018
- Posted
- March 20, 2018
- Terminated
- October 31, 2018
- Recall Number
- Z-1317-2018
- Quantity
- 59 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US, Puerto Rico, Malaysia
Lot / Code Info
Lot Number 17GM04522
Root Cause
Under Investigation by firm
Action Taken
The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.
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