Recall Z-1317-2018
Smith & Nephew, Inc. · initiated March 7, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 SCREW, REF 74692410, QTY (1), STERILE R
Codes / lots: Lot Number 17GM04522
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.
FDA-determined 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.
Details
- Recall number
- Z-1317-2018
- Initiated
- March 7, 2018
- Posted by FDA
- March 20, 2018
- Terminated
- October 31, 2018
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 59 units
- Distribution
- US, Puerto Rico, Malaysia
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN