Agency classClass IIOur severity:High FDA (Devices)·Z-1737-2015·Announced 2015-06-17

Smith & Nephew R3 Constrained Liner Recalled for Sizing Defect

Smith & Nephew is recalling 12 units of R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

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 that may prevent proper engagement of the locking ring, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Smith & Nephew, Inc. is recalling 12 units of the R3 Constrained Liner (Ref 71339158) due to a manufacturing defect. The product is a cemented or uncemented prosthesis intended to replace a hip joint, specifically 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 not allow the locking ring to engage into the R3 shell. The affected lot numbers are 14GM08613 and 14HM08037.

The affected units were 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. Healthcare providers and patients should contact Smith & Nephew for instructions on how to return or replace the affected devices.

The recalled product

Product: R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, 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
mechanical-failure
Affected units: 12

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: 14GM08613
14HM08037

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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