FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: 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
- Recall number
- Z-1317-2018
- Recalling firm
- Smith & Nephew, Inc.
- 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
- Status
- Terminated
- Initiated
- 2018-03-07
- Posted
- 2018-03-20
- Terminated
- 2018-10-31
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- The firm initiated their recall by letter and email on 03/07/2018. The firm requested return of the product.
- Quantity
- 59 units
- Distribution
- US, Puerto Rico, Malaysia
- Lot, serial or model codes
- Lot Number 17GM04522
- 510(k) numbers
- K132296
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28