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Terminated

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

FDA Recall Z-1856-2017 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2017-03-09
Date Terminated2019-08-21
Product Quantity100 units

Reason for Recall

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

Firm 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 [email protected]. For questions regarding this recall call 978-749-1440.

Root Cause

Labeling Change Control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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