Recall Z-0351-2017— Smith & Nephew, Inc.

Name: FDA recall Z-0351-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-29

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-08-29, terminated 2019-08-16. It names one FDA 510(k) clearance: K023743. Product: TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047. Reason: Some Bipolar shells were manufactured with an out of specification retainer groove..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-29
Terminated: 2019-08-16
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K023743 — SMITH & NEPHEW GLOBAL BIPOLAR SYSTEMSmith & Nephew, Inc.·cleared 2003-01-23

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

TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047

Reason for recall

Some Bipolar shells were manufactured with an out of specification retainer groove.

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