Recalls / —

—#154046

Product

D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K132296

Affected lot / code info

Batch number 14MM07780R

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 #154046. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.