Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall
Smith & Nephew is recalling 72 units of Legion CR XLPE Articular Inserts because the inner and outer packaging pouches were inadvertently sealed together.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging-only problem where the inner and outer pouches were sealed together, which falls under the 'packaging-only problems' criterion for a Low severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling 72 units of the LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122. The affected products are designed for use in primary and revision knee surgery where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The recall was initiated because the affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. This packaging error affects specific batch numbers: 09FM04561, 14AM05774, and 15GM11501.
The affected units were distributed in the United States, Canada, Great Britain, Australia, Italy, Germany, Malaysia, and Singapore. Healthcare providers and patients should check their inventory and patient records for these specific reference and batch numbers. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to their instructions.
The recalled product
- Product
- smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 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.
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch Numbers: 09FM04561
- 14AM05774 & 15GM11501
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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