The Recall Desk
SevereFDA (Devices)·Z-1736-2015·Announced 2015-06-17

Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a structural defect in a medical device that could lead to significant injury or device failure is rated as Severe (4).

Plain-English summary

Smith & Nephew, Inc. is recalling the R3 Constrained Liner, a medical device used as part of a hip joint replacement system. The specific product affected is the R3 22 MM I.D., 56 MM O.D. Constrained Liner, Reference 71339156, sterile ethylene oxide (EO), Lot 14JM02623.

The recall was initiated because the locking groove diameter on the outer liner is 0.030 inches oversized. This defect may prevent the locking ring from engaging into the R3 shell as intended. The device is intended for primary or revision patients at high risk for hip dislocation.

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 proceed with the recall.

The recalled product

Product
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, 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 pat
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
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)

  • Lot numbers: 14JM02623

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 →

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