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.
This recall has been terminated (originally issued March 30, 2018).
- Company
- Smith & Nephew Inc
- Recall Initiated
- March 30, 2018
- Terminated
- August 21, 2019
- Recall Number
- Z-1907-2018
- Quantity
- 47 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Distribution
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Lot / Code Info
Batch Numbers: 08BM09288; 12EM05884 & 12EM07720
Root 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.
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