Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall
Smith & Nephew is recalling 47 units of Legion CR XLPE 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 for a packaging-only problem (inner and outer pouches sealed together) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only issues.
Plain-English summary
Smith & Nephew, Inc. is recalling 47 units of the LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM (REF 71453101). The affected products were inadvertently packaged with the inner packaging pouch sealed together with the outer pouch. This recall involves specific batch numbers: 08BM09288, 12EM05884, and 12EM07720.
The affected products are 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 distribution pattern for these units includes the US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, and Singapore.
Consumers and healthcare providers should stop using the affected products and contact Smith & Nephew, Inc. for further instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 47
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: 08BM09288
- 12EM05884 & 12EM07720
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Smith & Nephew, Inc.
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
Same hazard · packaging error
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18