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Terminated

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 Recall Z-1317-2018 · Posted 2018-03-20

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2018-03-07
Date Terminated2018-10-31
Product Quantity59 units

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.

Firm Action

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

Root Cause

Under Investigation by firm

Distribution Pattern

US, Puerto Rico, Malaysia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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