Device product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Z-0448-2014
Product summary
- Event
- Event 66333
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 pieces
- Official record key
device-enforcement:Z-0448-2014
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. 12GT20775
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
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.