Recall Z-1904-2018— Smith & Nephew, Inc.

Name: FDA recall Z-1904-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-30

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2018-03-30, terminated 2019-08-21. It names one FDA 510(k) clearance: K071071. Product: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.. Reason: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-30
Terminated: 2019-08-21
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

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

Reason for recall

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

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