Device product
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Z-1906-2018
Product summary
- Event
- Event 79875
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1906-2018
Official wording
Reason: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Code information: Batch Numbers: 11DM11664 & 15BM09445
Distribution pattern: US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Derived failure modes
-
Unknown
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.