Recall Z-1735-2015— Smith & Nephew, Inc.

Name: FDA recall Z-1735-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-06

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2015-05-06, terminated 2022-04-01. It names one FDA 510(k) clearance: K083566. Product: R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, 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: 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..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-05-06
Terminated: 2022-04-01
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K083566 — R3 CONSTRAINED LINER, CONSTRAINED LINERSmith & Nephew, Inc.·cleared 2009-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.