Z-1907-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- March 30, 2018
- Termination Date
- August 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 units
Product Description
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Reason for Recall
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Distribution Pattern
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Code Information
Batch Numbers: 08BM09288; 12EM05884 & 12EM07720