D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD
FDA device recall Z-1317-2018 · posted 2018-03-20 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- 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.
- Action taken
- The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 59 units
- Distribution
- US, Puerto Rico, Malaysia
- Date initiated
- 2018-03-07
- Date posted
- 2018-03-20
- Date terminated
- 2018-10-31
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| D-RAD SMART PACK (K132296) | Smith & Nephew, Inc. | 2014-01-07 |