Recall Z-1507-2020— Smith & Nephew, Inc.

Name: FDA recall Z-1507-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-19

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2019-12-19, terminated 2024-09-04. It names one FDA 510(k) clearance: K071071. Product: LEGION PS High Flex XLPE size 5-6 9mm Articular Insert. Reason: LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part.

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-19
Terminated: 2024-09-04
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K071071 — CROSSLINKED POLYETHYLENE ARTICULAR INSERTSSmith & Nephew, Inc.·cleared 2007-09-19

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

LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

Reason for recall

LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part

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