Recall Z-1857-2017 ยท HWC Screw, Fixation, Bone
Smith & Nephew, Inc.
D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424
| Date | Mar 9, 2017 |
| Status | Terminated |
| Reason | The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. |
| Root cause | Labeling Change Control |
| Action | Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact FieldAction@smith-nephew.com. For questions regarding this recall call 978-749-1440. |
| Quantity | 197 units |
| Distribution | Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132296 | D-RAD SMART PACK Smith & Nephew, Inc., Jan 7, 2014 |