Device 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
Z-1317-2018
Product summary
- Event
- Event 79515
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59 units
- Official record key
device-enforcement:Z-1317-2018
Official wording
Reason: 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.
Code information: Lot Number 17GM04522
Distribution pattern: US, Puerto Rico, Malaysia
Derived failure modes
-
Potency or specification failure
out of specification