# FDA recall Z-1317-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2018-03-07.

## 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

## 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

US, Puerto Rico, Malaysia

## Key facts

- **Recall number:** Z-1317-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-07
- **Report date:** 2018-04-18
- **Termination date:** 2018-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1317-2018

## Citation

> AI Analytics. FDA recall Z-1317-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1317-2018. Source: US FDA. Licensed CC0.

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