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
This recall has been terminated (originally issued March 9, 2017).
- Company
- Smith & Nephew Inc
- Recall Initiated
- March 9, 2017
- Terminated
- August 21, 2019
- Recall Number
- Z-1857-2017
- Quantity
- 197 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Distribution
Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore
Lot / Code Info
Batch numbers: (a) RES 74692410: 15GM13481, 15JM17474, 15JM17475 (b) RES 74692412: 15EM010131, 15JM07539 (c) RES 74692416: 15FM06118 (d) RES 74692422: 16AM19135 (e) RES 74692424: 15JM19559
Root Cause
Labeling Change Control
Action Taken
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.