—#162539

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

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K132296
Affected lot / code info: Lot Number 17GM04522

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: US, Puerto Rico, Malaysia

Timeline

Recall initiated: 2018-03-07
Posted by FDA: 2018-03-20
Terminated: 2018-10-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162539. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.