FDA-Device2018-04-18Class II
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
Smith & Nephew, Inc.
Hazard
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.
Sold states
US, Puerto Rico, Malaysia
Affected count
59 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1317-2018Don't want to check this manually?
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