Recall Z-1317-2018 ยท HWC Screw, Fixation, Bone
Smith & Nephew, Inc.
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
| Date | Mar 20, 2018 (initiated Mar 7, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product. |
| Quantity | 59 units |
| Distribution | US, Puerto Rico, Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132296 | D-RAD SMART PACK Smith & Nephew, Inc., Jan 7, 2014 |