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Recall Observatory FDA recall evidence

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

March 07, 2018

Class II

Product summary

Firm
Smith & Nephew, Inc.
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

    reason.potency_specification_failure · v1.0.0

    out of specification