Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall
Smith & Nephew is recalling Legion CR XLPE High Lexion Articular Inserts due to a packaging error where inner and outer pouches were 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 classified as FDA Class II, but the source text describes a packaging-only problem (inner and outer pouches sealed together) without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a Low severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling the Legion(R) CR XLPE High Lexion Articular Insert, 5-6 Size, 9 MM, REF 71453121. This medical device is designed for use in patients undergoing primary and revision 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 sealed together with the outer pouch. This packaging error affects specific batches identified by batch numbers 11DM11664 and 15BM09445.
The affected products were distributed in the United States, Canada, Great Britain, Australia, Italy, Germany, Malaysia, and Singapore. Healthcare providers and patients should check their inventory or medical records for these specific batch numbers and contact Smith & Nephew for further instructions.
The recalled product
- 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.
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
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 (1)
- Batch Numbers: 11DM11664 & 15BM09445
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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