D-RAD Self-Tapping Locking Screw intended for the fixation… recallZ-1317-2018 · Smith & Nephew, Inc. · initiated Mar 7, 2018
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.
Recall details
- Recall number
- Z-1317-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 7, 2018
- Posted by the FDA
- Mar 20, 2018
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 59 units
- Product code
- HWC
- FDA submissions
- K132296
- Distribution
- US, Puerto Rico, Malaysia
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
Code information (models, lots, serial numbers)
Lot Number 17GM04522
Other devices under the same FDA submission
7 devices cleared under K132296 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- D-RAD SMART PACK 71158019Smith & Nephew, Inc. · PLATE, FIXATION, BONE10 reports
- D-RAD SMART PACK 71158022Smith & Nephew, Inc. · PLATE, FIXATION, BONE9 reports
- D-RAD SMART PACK 71158021Smith & Nephew, Inc. · PLATE, FIXATION, BONE7 reports
- D-RAD SMART PACK 71158020Smith & Nephew, Inc. · PLATE, FIXATION, BONE4 reports
- D-RAD SMART PACK 74682412Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- D-RAD SMART PACK 74682414Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- D-RAD SMART PACK 74692422Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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