Skip to content
Recall Observatory FDA recall evidence

Device product

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Z-0445-2014

August 27, 2013

Class II

Product summary

Firm
Smith & Nephew Inc
Event
Event 66333
Status
Terminated
Classification
Class II
Quantity
45 pieces
Official record key
device-enforcement:Z-0445-2014

Official wording

Reason: 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.

Code information: Batch No. 12GT20824

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.