Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1317-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 7, 2018

Date Posted: April 18, 2018

Recall Number: Z-1317-2018

Event ID: 79515

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.

Status: Terminated

Product Quantity: 59 units

Code Information:

Lot Number 17GM04522

Distribution Pattern:

US, Puerto Rico, Malaysia

Voluntary or Mandated:

Voluntary: Firm initiated