Z-1317-2018Class II

D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius...

Name: Z-1317-2018 D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius...
Creator: Smith & Nephew, Inc.
Published: 2018-03-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-03-07 / Terminated

FDA source

Smith & Nephew, Inc. began a recall of 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... on 2018-03-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1317-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-07
Posted: 2018-03-20
Terminated: 2018-10-31
Recalling firm: Smith & Nephew, Inc.
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
Product code: HWC Screw, Fixation, Bone
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.
FDA 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 in commerce: 59 units
Distribution: US, Puerto Rico, Malaysia
Product codes and lots: Lot Number 17GM04522

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1317-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1317-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-06

Product code HWC

K132296Class IID-Rad Smart PackSmith & Nephew, Inc. / cleared 2014-01-07

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)