Recall Z-1906-2018
Smith & Nephew, Inc. · initiated March 30, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Batch Numbers: 11DM11664 & 15BM09445
Reason for recall
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
FDA-determined cause: Packaging process control
Action taken
The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
Details
- Recall number
- Z-1906-2018
- Initiated
- March 30, 2018
- Terminated
- August 21, 2019
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Distribution
- US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1904-2018 Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF…The affected products were inadvertently packaged with the inner packaging pouch being sealed together with… | 03/30/2018Terminated |
| Z-1905-2018 Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF…The affected products were inadvertently packaged with the inner packaging pouch being sealed together with… | 03/30/2018Terminated |
| Z-1907-2018 Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF…The affected products were inadvertently packaged with the inner packaging pouch being sealed together with… | 03/30/2018Terminated |