Recall Z-1929-2013— Smith & Nephew Inc

Name: FDA recall Z-1929-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-29

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2013-05-29, terminated 2016-03-22. It names one FDA 510(k) clearance: K113848. Product: R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.. Reason: One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-29
Terminated: 2016-03-22
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K113848 — R3 XLPE LINERSSmith & Nephew, Inc.·cleared 2012-04-27

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) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.

Reason for recall

One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.

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