smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 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.
Reported: May 30, 2018 Initiated: March 30, 2018 #Z-1904-2018
Product Description
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 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.
Reason for Recall
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 16 units
- Distribution
- US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 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.. Recalled by Smith & Nephew, Inc.. Units affected: 16 units.
Why was this product recalled? ▼
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 30, 2018. Severity: Moderate. Recall number: Z-1904-2018.
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