Smith & Nephew Inc: Medical Device Recall in 2013 - (Recall #: Z-0446-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Product Classification:

Class II

Date Initiated: August 27, 2013

Date Posted: December 11, 2013

Recall Number: Z-0446-2014

Event ID: 66333

Reason for Recall:

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Status: Terminated

Product Quantity: 80 pieces

Code Information:

Batch No. 12GT20822

Distribution Pattern:

Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated