Recall Z-0446-2014— Smith & Nephew Inc

Name: FDA recall Z-0446-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-27

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2013-08-27, terminated 2019-08-20. It names one FDA 510(k) clearance: K032295. Product: GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic. Reason: The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2013-08-27
Terminated: 2019-08-20
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K032295 — GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERTSmith & Nephew, Inc.·cleared 2003-08-21

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

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Reason for recall

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

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