Z-1317-2018 Class II Terminated
FDA device recall Z-1317-2018 was initiated by Smith & Nephew, Inc. on Mar 7, 2018 and is designated Class II. 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. The recall status is terminated (terminated Oct 31, 2018). Affected quantity: 59 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 18, 2018
- Initiation Date
- Mar 7, 2018
- Termination Date
- Oct 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units
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
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.
Distribution Pattern
US, Puerto Rico, Malaysia
Code Information
Lot Number 17GM04522
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1317-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026