Recall Z-0350-2017— Smith & Nephew, Inc.

Name: FDA recall Z-0350-2017
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) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057. 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) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057

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.