Agency classClass IIOur severity:High FDA (Devices)·Z-1735-2015·Announced 2015-06-17

Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

Smith & Nephew is recalling 17 units of the R3 Constrained Liner because the locking groove is oversized, potentially preventing the locking ring from engaging.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device intended for high-risk patients, creating a risk of harm (instability) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Smith & Nephew, Inc. is recalling 17 units of the R3 Constrained Liner (Ref 71339152) due to a manufacturing defect. The product is a cemented or uncemented prosthesis intended to replace a hip joint, specifically designed for patients at high risk for hip dislocation.

The recall is issued because the R3 Constrained outer liner locking groove diameter is 0.030 inches oversized. This defect may prevent the locking ring from engaging into the R3 shell, which could compromise the stability of the hip prosthesis.

The affected units are distributed worldwide, including in the United States (CA, FL, IL, IN, MI, NE, NY, TN, TX, VA, WI) and in Australia, Switzerland, Chile, Canada, and Spain. The specific lot numbers involved are 14HM08235 and 14KM08473. Healthcare providers and patients should contact Smith & Nephew for further instructions on how to manage the recalled devices.

The recalled product

Product: R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: structural-defect
device-instability
Affected units: 17

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)

Lot numbers: 14HM08235
14KM08473

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Smith & Nephew, Inc.

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