The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1904-2018·Announced 2018-05-30

Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

Smith & Nephew is recalling 16 units of Legion CR XLPE Articular Inserts because the inner packaging pouch was inadvertently sealed with the outer pouch.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a packaging defect (inner pouch sealed with outer pouch) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Smith & Nephew, Inc. is recalling 16 units of the LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185. The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

The recall involves Batch Number 16EM12620. The products were distributed in the US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, and Singapore. The device is 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.

Consumers and healthcare providers should stop using the affected products and contact Smith & Nephew for further instructions.

The recalled product

Product
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.
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
16

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 Number 16EM12620

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 →

Same hazard · packaging defect

See all →

Similar recalls