Recall Z-0730-2019— Smith & Nephew, Inc.

Name: FDA recall Z-0730-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-07

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2019-01-07, terminated 2020-09-17. It names one FDA 510(k) clearance: K123598. Product: SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613. Reason: The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-07
Terminated: 2020-09-17
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K123598 — SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.·cleared 2013-06-28

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

SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613

Reason for recall

The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

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