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Smith & Nephew, Inc. recalls R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usage: The R3 Constrain
Recalled June 17, 2015 · FDA recall Z-1739-2015 · Smith & Nephew
Hazard
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. · FDA Class II
Units
32 units
Sold at
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
Description
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.
Product
R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, 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.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →