PlainRecalls
FDA Devices Moderate Class II Terminated

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 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

Reported: June 17, 2015 Initiated: May 6, 2015 #Z-1737-2015

Product Description

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 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.

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.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
12 units
Distribution
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
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
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 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.. Recalled by Smith & Nephew, Inc.. Units affected: 12 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1737-2015.

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