D-RAD Self-Tapping Locking Screw intended for the fixation of… — Class II medical device recall Z-1317-2018
Terminated recall by Smith & Nephew, Inc., reported 2018-04-18, distributed in PR. One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of spec
| Recall number | Z-1317-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2018-03-07 |
| Classified | 2018-04-06 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2018-10-31 |
| Distributed | PR |
| Countries outside the US | MY |
| Quantity | 59 units |
| Reason classes | specification failure, device malfunction |
| Lot numbers | 17GM04522 |
| Model numbers | 74692410 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1317-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.