Z-1856-2017 Class II Terminated

Recalled by Smith & Nephew, Inc. — Memphis, TN

FDA device recall Z-1856-2017 was initiated by Smith & Nephew, Inc. on March 9, 2017 and is designated Class II. Reason for recall: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. The recall status is terminated (terminated August 21, 2019). Affected quantity: 100 units.

Recall Details

Product Type
Devices
Report Date
April 26, 2017
Initiation Date
March 9, 2017
Termination Date
August 21, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Batch number 14MM07780R