The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1738-2015·Announced 2015-06-17

Smith & Nephew R3 Constrained Liner Recalled for Locking Groove Defect

Smith & Nephew is recalling 40 units of R3 Constrained Liners because the locking groove is oversized, preventing 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device (hip prosthesis) that may prevent proper mechanical engagement, posing a significant risk of injury or device failure.

Plain-English summary

Smith & Nephew, Inc. is recalling 40 units of the R3 Constrained Liner, Reference 71339160. The product is a sterile, single-use acetabular component intended for primary or revision hip replacement in patients at high risk for dislocation. The recall covers specific lot numbers: 16HM08087, 14HM08097, 14HM08133, 14HM08141, and 14JM21517.

The recall is due to a manufacturing defect where 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 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 returning the product or obtaining a replacement.

The recalled product

Product
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, 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
Affected units
40

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 (5)

  • Lot numbers: 16HM08087
  • 14HM08097
  • 14HM08133
  • 14HM08141
  • and 14JM21517

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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