Recall Z-2427-2012— Smith & Nephew Inc

Name: FDA recall Z-2427-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-22

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2012-08-22, terminated 2013-02-27. It names one FDA 510(k) clearance: K081124. Product: 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.. Reason: Modular necks were manufactured out of specification by a vendor; the taper provide is undersized..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2012-08-22
Terminated: 2013-02-27
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K081124 — MDF REVISION HIP SYSTEMSmith & Nephew, Inc.·cleared 2008-07-31

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

12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.

Reason for recall

Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.

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