—#154047

Product

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

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K132296
Affected 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

Why it was recalled

The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore

Timeline

Recall initiated: 2017-03-09
Terminated: 2019-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154047. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.