Recall Z-0143-2022— Smith & Nephew, Inc.

Name: FDA recall Z-0143-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-20

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2021-09-20, terminated 2023-03-24. It names one FDA 510(k) clearance: K060736. Product: 6.5MMX165MM CANNULATED SCREW. Reason: The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-09-20
Terminated: 2023-03-24
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K060736 — SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWSSmith & Nephew, Inc.·cleared 2006-04-18

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

6.5MMX165MM CANNULATED SCREW

Reason for recall

The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

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