Smith & Nephew, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1738-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.

Product Classification:

Class II

Date Initiated: May 6, 2015

Date Posted: June 17, 2015

Recall Number: Z-1738-2015

Event ID: 71330

Reason for Recall:

The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.

Status: Terminated

Product Quantity: 40 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of CA, FL, IL, IN, MI, NE, NY, TN, TX, VA, WI and the countries of Australia, Switzerland, Chile, Canada, and Spain

Voluntary or Mandated:

Voluntary: Firm initiated